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List of Recommended for Use of Covid-19 IVD Test kit (Professional use only)

SPECIAL ACCESS LIST OF COVID-19 TEST KIT (FOR PROFESSIONAL USE ONLY)

The list of Covid-19 Antibody, Antigen and Nucleic Acid Amplification Test (NAAT) that is recommended for use based on the decision on the consensus of the Covid-19 Test Kit Expert committee is as follows.

All test submissions are scored according to: -

  • the manufacturer reported clinical and analytical performance
  • the evaluation test results from testing facilities are according to the committee evaluation criteria set by Clinical expert
  • Supporting Documents for COVID-19 IVD Test Kits Special Access

Below is the list of all tests that have been selected to date and the status is Recommended for Use (please note: list is updated on a routine basis).

Notes:

*Sample type and lot number is based on testing facility evaluation report.

NO

COMPANY NAME

PRODUCT NAME

MANUFACTURER

IDENTIFIER

LOT NUMBER*

DETECTION

SAMPLE TYPE*

1.

Science Valley Sdn Bhd

STANDARD™ Q COVID-19 Ag Test

SD Biosensor, Inc. Republic of Korea

Reference No: Q-NCOV-01G

Catalogue No: 09COV30D

QC03020019A

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

2

NeoScience Sdn Bhd

NowCheck Covid-19 Ag Test

BioNote, Inc.

Republic of Korea

RG1901DG

1901D001

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

3

Axisbio Diagnostic Sdn Bhd

Quidel SOFIA 2 SARS Antigen FIA

Quidel Corporation. CA, USA

20374

141493

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

4

Science Valley Sdn Bhd

STANDARD F COVID-19 Ag FIA

SD Biosensor, Inc. Republic of Korea

Reference No.: F-NCOV-01G
Catalogue No.: 10 COV 30D

FCO302006041

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

5

Premier Diagnostics Sdn Bhd

ecotest COVID-19 Antigen Rapid Test Device (Respiratory Specimens)

Assure Tech. (Hangzhou) Co., Ltd. P.R. China

cov-w23M
cov-s23

SR20070002

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

6

Alere Health Sdn Bhd / Abbott Laboratories

Panbio™ COVID-19 Ag Rapid Test Device

Abbott Rapid Diagnostics Jena GmbH Germany

41FK10

N/A

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

7

Citymedic Sdn Bhd

Gmate® COVID-19 Ag

Philosys Co., Ltd

Republic of Korea

AG-019

20200922

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

8

Roche Diagnostics (M) Sdn Bhd

SARS-CoV-2 Rapid Antigen Test

SD Biosensor

Republic of Korea

9901-NCOV-01G

QCO3020109

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

9

Medical Innovation Ventures Sdn Bhd

ProDetect® COVID-19 Antigen Rapid Test

Medical Innovation Ventures Sdn. Bhd. Penang, Malaysia

PR-CVDAg

PRCVDCAg20NOV04

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

10

Klinik Gemilang

VivaDiag™ SARS-CoV-2 Ag Rapid Test

VivaChek Biotech (Hangzhou) Co., Ltd. P.R. China

VCD05-01-011

SE2010016

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

11

Everest Medical Resources (M) Sdn Bhd

VivaDiag™ SARS-CoV-2 Ag Rapid Test

VivaChek Biotech (Hangzhou) Co., Ltd. P.R. China

VCD05-01-011

SYE2009027

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

12

Malaysian Diagnostics Corporation Sdn Bhd

SGTi-flex COVID-19 Ag

Sugentech, Inc.

Republic of Korea

CAGT-0xx-O

CAGT-0xxEx

CAGT20002

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

13

MYEG Medical Service Sdn Bhd

SGTi-flex COVID-19 Ag

Sugentech, Inc.

Republic of Korea

CAGT-0xx-O

CAGT-0xxEx

N/A

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

14

EB Holdings Sdn Bhd

SGTi-flex COVID-19 Ag

Sugentech, Inc.

Republic of Korea

CAGT-0xx-O

CAGT-0xxEx

CAGT20004

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

15

Malaysian Diagnostics Corporation Sdn Bhd

Humasis COVID-19 Ag Test

Humasis Co., Ltd., Republic of Korea.

ACOVA-7025

COVGNP0001

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

16

Merlin Medic Sdn Bhd

Healgen® Coronavirus Ag Rapid Test Cassette (Swab)

Healgen Scientific Limited Liability Company, USA

N/A

2011390

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

17

Arey Solutions Sdn Bhd

DIAKEY COVID-19 Ag Rapid Test

Shinjin Medics Inc. Republic of Korea

PF10

E272001A01

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

18

Daiichi Biotech Services Sdn Bhd

UNICELL-2019-nCoV Ag

Shenzhen YHLO Biotech Co., LTD, P.R. China

XHLO
F86242

20201102

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

19

Kaspur Medical Supplies (M) Sdn Bhd

Jinwofu Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Kit Lot # : 20201102

Beijing Jinwofu Bioengineering Technology Co.,Ltd. P.R China.

C3042

20201102

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

20

Medicara Sdn Bhd

Jinwofu Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Kit Lot # : 20201102

Beijing Jinwofu Bioengineering Technology Co.,Ltd. P.R China.

C3042

20201102

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

21

Azion  Healthcare Sdn Bhd

Jinwofu Novel Coronavirus (SARS-CoV-2) Antigen Rapid

Beijing Jinwofu Bioengineering Technology Co.,Ltd. P.R China.

C3042

E20210302

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

22

Trust Diagnostics Sdn Bhd

LEPU SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Immunochromatography)

Beijing Lepu Medical Technology Co., Ltd. P.R. China

N/A

20CG2715X

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

23

TEDA Wellness Solutions Sdn Bhd

Lyher Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)

Hangzhou Laihe Biotech Co., Ltd.

P.R. China

LYHER AG RTK

2011047

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

24

Brighton Occuhealth Services Sdn Bhd

FASTEP Covid-19 Antigen Rapid Test Device

Assure Tech (Hangzhou) Co. Ltd., Zhejiang, P.R. China

COV-S23

SR2020012028

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

25

Translab (M) Sdn Bhd

Helix i-SARS-CoV-2 Ag Rapid Test

Cellex, Inc. 76 TQ Durham NC USA

i-101

20201102

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

26

Top Biotech Sdn Bhd

TOP RAPID COVID-19 Rapid Antigen Test Kit

Top Biotech Sdn Bhd Subang Jaya, Selangor,

Premium model (with accessory) Base model (without accessory)

TBCV030021025

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

27

Tri-G Technologies Sdn Bhd

RightSign SARS-CoV-2 Antigen Rapid Test Cassette

Hangzhou Biotest Biotech Co. Ltd., Hangzhou, China

INCP-C81

COVG2102009-S

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

28

MyVantros Sdn Bhd

Coronavirus Ag Rapid Test Cassette (Swab)

Zhejiang Orient Gene Biotech Co., Ltd. , Zhejiang, China

N/A

2011036

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

29

VQUEST Sdn Bhd

SARS-CoV-2 Antigen Test kit

Shenzhen Ultra-Diagnostics Biotec. Co., Ltd. P.R.China

SC0202

20122101

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

30

Hyperion Sdn Bhd

NATEJAH COVID-19 Antigen Rapid Test (Swab)

Lana Al Khaleej Al Awal Factory for Medical Supplies Second Industrial City, Kingdom of Saudi Arabia

LA24-1002

Sample

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

31

Translab (M) Sdn Bhd

NADAL® COVID-19 Ag Test (test cassette)

nal von minden GmbH Germany

243103N-20

175202

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

32

HWGB Medical Devices & Supplies Sdn Bhd

SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method)

Wenzhou OJA Biotechnology Co., Ltd. P.R China

N/A

ZKHT21020201

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

33

JKS Biomedical

Getein Biotech GP One Step Test For Sars-Cov-2 Antigen (Colloidal Gold)

Getein Biotech, Inc Nanjing, China

CG2061

6SC210007WF1

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

34

Jingga Anggun Sdn Bhd

Longsee 2019-nCoV Ag & Influenza A/B Ag Rapid

Co-Detection Kit

Guangdong Longsee Biomedical Co.,Ltd

Guangzhou, P.R. China

LS-C-T-005

CT005201205

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

35

ER Medicare

Hotgen Novel Coronavirus 2019-nCoVAntigen Test (Colloidal Gold)

Beijing Hotgen Biotech Co., Ltd. Beijing, P.R. China.

688068.SH

W2020113900

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

36

Interscience Sdn Bhd

StrongStep SARS-CoV-2 Antigen Rapid Test

Nanjing Liming Bio-products Co. Ltd. Jiangsu P.R. China

500200

2011012

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

37

Almedico Sdn Bhd

LabGun™ COVID-19 Rapid Antigen Kit

CALTH Inc.
Republic of Korea

CHR11L

EX-CHR11L-2006

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

38

DiagnostiCARE Sdn Bhd

Lifotronic SARS-CoV-2 Antigen (GICA)

Shenzhen Lifotronic Technology Co., Ltd.,P.R. China

320300102

YF8520004

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

39

Biomarketing Services (M) Sdn Bhd

Lifotronic SARS-CoV-2 Antigen (GICA)

Shenzhen Lifotronic Technology Co., Ltd. P.R. China

320300102

SAR2101500

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

40

SPD Scientific (M) Sdn Bhd

Innova SARS-CoV-2 Antigen Rapid Qualitative Test

Innova Medical Group, Inc., USA

BT 1309

X2101038

RTK Antigen

Nasal or throat swab

41

MY Big Sdn Bhd

GeneFinder™ COVID-19 Ag Rapid Test

OSANG Healtcare Co., Ltd, Gyeonggi-do, Korea

INFI01ACA

SN-2012-01

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

42

Siemens Healthcare Sdn Bhd

CLINITEST Rapid COVID-19 Antigen Test

Healgen Scientific Limited Liability Company., Houston USA.

11555845

2010189

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

43

ACCOBIOTECH Sdn Bhd

ACCO COVID-19 Ag

ACCOBIOTECH Sdn Bhd, Johor, Malaysia

ACCOVAG125

FMFPO 2201

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

44

Silver State Laboratory Sdn Bhd

COVID-19 ANTIGEN RAPID TEST (Colloidal Gold)

Joinstar Biomedical Technology Co Ltd Hangzhou, China.

FGCOVG1300

CAG2103008G

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

45

Bioworld Technologies Sdn Bhd

GENEDIA W COVID-19 Ag

Green Cross Medical Science Corp.

643G

643G2012

RTK Antigen

Nasopharyngeal or oropharyngeal swab samples

46

Dewina Consult Sdn
Bhd

Newgene Bioengineering COVID-19 Antigen Detection Kit

New Gene (Hangzhou) Bioengineering Co.,Ltd.,China.

Covid-19-NG08

20210228-01

RTK Antigen

Deep throat saliva (DTS)

47

Exza Medical Sdn Bhd

Medomics SARS-CoV-2 Antigen Test Kit (LFIA)

Jiangsu Medomics Medical Technology Co., Ltd., Jiangsu, China

N/A

2021012907

RTK Antigen

Nasopharyngeal swabs or oropharyngeal swabs

48

Holista Biotech Sdn Bhd

Hecin 2019-nCoV Antigen Test Kit (colloidal gold method)

Guangdong Hecin Scientific, Inc.,China

2019-nCoV Antigen test kit (Colloidal gold method)

20210313

RTK Antigen

Nasopharyngeal swabs or oropharyngeal swabs

49

VQM Marketing Sdn Bhd

Alltest COVID-19 Antigen Rapid Test (Nasopharyngeal Swab)

Hangzhou Alltest Biotech Co., Ltd., Hangzhou, China

ICoV-502

ATCOV21010138

RTK Antigen

Nasopharyngeal swabs or oropharyngeal swabs

50

Neopharma Biotech Asia Sdn Bhd

AllCheck COVID19 Ag Kit

CALTH Inc.

CHR11

CHR11cF2103

RTK Antigen

Nasopharyngeal swabs

51

Medcos International
Sdn Bhd

Asan Easy Test COVID-19 Ag

Asan Pharmaceutical Co.,Ltd Gyeonggi-do, Korea

AM3474-K (20T)

AM3476-K (25T)

EKF002c

RTK Antigen

Nasopharyngeal swabs and oropharyngeal swabs

52

Tradebiz Marketing Sdn Bhd

InstantSure Covid-19 Ag CARD

Suzhou Soochow University Saier Immuno Biotech Co., Ltd

InstantSure Covid-19 Ag CARD

20210204

RTK Antigen

Nasopharyngeal swabs and oropharyngeal swabs

53

Instrumatrix Technology Sdn Bhd

NOVA Test SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold Immunochromatography)

Atlas Link Technology Co., Ltd, People's Republic of China

nCoV-500

202110305

RTK Antigen

Nasopharyngeal swab & Oropharyngeal swabs

54

BMS Diagnostics (M) Sdn Bhd

Kaibili™ Covid-19 Antigen

Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.

P211134

GP210101P

RTK Antigen

Nasopharyngeal swab or Oropharyngeal swabs

55

BMS Diagnostics (M) Sdn Bhd

Kaibili™ Covid-19 Antigen Neo

Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.

P211136

GP210301P

RTK Antigen

Nasopharyngeal swab or Oropharyngeal swabs

56

NeoScience Sdn Bhd

Standard Q COVID-19 Ag Saliva Test

SD Biosensor Inc, Korea

REF: Q-NCOV-02G

Catalog no. 09COV90D

QC09020006

RTK Antigen

Deep throat saliva

57

Medinics (M) Sdn Bhd

VivaDiag™ SARS-CoV-2 Ag Saliva Rapid Test

VivaCheck Biotech (Hangzhou) Co., Ltd

VCD17-01-012

SE2103027

RTK Antigen

Saliva

58

Pharmaniaga Marketing Sdn Bhd

VivaDiag™ SARS-CoV-2 Ag Saliva Rapid Test

VivaCheck Biotech (Hangzhou) Co., Ltd

VCD17

SE2102094

RTK Antigen

Saliva

59

Pharmaniaga Marketing Sdn Bhd

VivaDiag™ Pro SARS-CoV-2 Ag Rapid Test

VivaCheck Biotech (Hangzhou) Co., Ltd

VivaDiag

SE2103063

RTK Antigen

Nasopharyngeal swab or Oropharyngeal swabs

60

VQM Marketing Sdn Bhd

ALLTEST COVID-19 Antigen Rapid Test (Oral Fluid)

Hangzhou AllTest Biotech Co., Ltd

ICOV-802

ATCOV2103212-S

RTK Antigen

Saliva

61

Teda Wellness Solutions Sdn Bhd

Lyher® Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)

Hangzhou Laihe Biotech Co. Ltd Zhejiang, People's Republic of China

303034

2103063

RTK Antigen

Nasopharyngeal swab & Oropharyngeal swab

62

HS Bio Supplies Sdn Bhd

Realy Tech Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Cassette (swab)

Hangzhou Realy Tech Co., Ltd

K511416D

202104032

RTK Antigen

Nasopharyngeal swab & Oropharyngeal swab

63

Medical Innovation Ventures Sdn Bhd

ProDetect® COVID-19 Antigen Rapid Test (Oral Fluid)

Medical Innovation Ventures Sdn Bhd

PR-CVDCAgO

PRCVDCAgO21MAY25

RTK Antigen

Oral fluid

64

Malaysian Diagnostics Corporation Sdn Bhd

ZYBIO SARS-CoV-2 Antigen assay Kit (Colloidal Gold)

Zybio Inc, Chongqing, China.

2061701

510410

RTK Antigen

Nasopharyngeal swab & Oropharyngeal swab

65

Unimed Sdn Bhd

Sensing Self S1 COVID19 Rapid Antigen Test Kit

Sensing Self Pte. Ltd. Singapore

ERCSSO5320

SS101027

RTK Antigen

Nasopharyngeal swab & Oropharyngeal swab

66

Chemopharm Sdn Bhd

PCL COVID-19 Ag Gold

PCL, Inc., Korea

COV04S

2105S811

RTK Antigen

Saliva

67

Chemopharm Sdn Bhd

PCL COVID-19 Ag Gold

PCL, Inc., Korea

COV04S

2105S811

RTK Antigen

Nasal swab

68

Chemopharm Sdn Bhd

PCL COVID-19 Ag Gold

PCL, Inc., Korea

COV04S

2105S811

RTK Antigen

Nasopharyngeal swab

69

Suria Medik Sdn Bhd

Artron COViID-19 Antigen Test

Artron Laboratories Inc., Canada.

A03-50-422

6-210610

RTK Antigen

Nasopharyngeal swab (NPS)

70

Hygeia Instrum ents (Malaysia) Sdn Bhd

NEWGENE Bioengineering COVID-19 Antigen Detection Kit

New Gene (Hangzhou) Bioengineering Co., Ltd.

Covid-19-NG08

20210228-01

RTK Antigen

Deep throat saliva (DTS)

71

Hygeia Instruments (Malaysia) Sdn Bhd

NEWGENE Bioengineering COVID-19 Antigen Detection Kit

New Gene (Hangzhou) Bioengineering Co., Ltd.

Covid-19-NG08

20210228-01

RTK Antigen

Nasopharyngeal Swab

72

Prova Lab & Research Sdn Bhd

Well Biotech COVID-19 Ag Rapid Saliva Test Device

Jiangsu Well Biotech Co., Ltd. China.

CO-03

202105181

RTK Antigen

Saliva

73

Neoscience Sdn Bhd

STANDARD™ Q COVID-19 Ag Test

SD Biosensor, Inc., Korea

09COV31D, 09COV33D

QC03120001A

RTK Antigen

Nasopharyngeal Swab (NPS)

74

Neoscience Sdn Bhd

STANDARD™ Q COVID-19 Ag Test

SD Biosensor, Inc., Korea

09COV31D, 09COV33D

QC03120001A

RTK Antigen

Nasal Swab

75

Abbott Diagnostics Health Sdn Bhd

Panbio™ COVID-19 Ag Rapid Test Device (NASAL)

Abbott Rapid Diagnostics Jena GmBH, Jena, Germany

41FK11

41ADG260B, 41ADF45OA

RTK Antigen

Nasal swab

76

AMD Solutions Sdn Bhd

Boson Biotech Rapid SARS-CoV-2 Ag Test Card

Xiamen Boson Biotech Co. Ltd., Xiamen, Fujian, P.R. China.

1N40C5

21040103

RTK Antigen

Nasal swab

77

Jingga Anggun Sdn Bhd

Longsee 2019-nCoV Ag & Influenza A/B Rapid Co-Detection Kit (immuno-chromatography)

Guangdong Longsee Biomedical Co. Ltd., Guangzhou, China

LS-C-T-005

CT005210531

RTK Antigen

Saliva

78

Infitos Sdn Bhd

JINJIAN SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method)

Hubei JinJian Biology Co., Ltd., China.

SARS-CoV-2-Ag02

210404

RTK Antigen

Nasopharyngeal swab (NPS)

79

Everest Medical Resources (M) Sdn Bhd

VivaDiag™ SARS-CoV-2 Ag Saliva Rapid Test

VivaCheck Biotech (Hangzhou) Co., Ltd.

VCD17-01-012

SE2103162

RTK Antigen

Saliva

80

Nano Medic Care Sdn Bhd

Flowflex™ SARS-CoV-2 Antigen Rapid Test

ACON Biotech (Hangzhou) Co. Ltd., P.R. China

L031-11825

20201028

RTK Antigen

Nasal swab

81

APSN Healthcare & Diagnostics Sdn Bhd

CiTest COVID-19 Antigen Rapid Test (Oral fluid)

CiTest Diagnostics Inc, Vancouver, Canada

INCP-CT802

COV21060055

RTK Antigen

Saliva

82

WFR Medical Supplies Sdn Bhd

WFR COVID-2019 Antigen Rapid Test Kit

WFR Medical Supplies Sdn BHd. Pulau Pinang, Malaysia.

WFR COVID-2019 Antigen Rapid Test Kit

2021061504

RTK Antigen

Nasopharyngeal swab (NPS) and Oropharyngeal swab (OPS)

83

Impian Orto Medik Sdn Bhd

JOYSBIO SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)

JOYSBIO (Tianjin) Biotechnology Co, Ltd., Tianjin, China.

G10314

2021022609

RTK Antigen

Saliva

84

Xinnerg Sdn Bhd

ACRO COVID-19 Antigen Rapid Test (Oral Fluid)

ACRO Biotech Inc

INCP-AC0802

COV21060052ACO

RTK Antigen

Saliva

85

Innovita Sdn Bhd

Wuhan EasyDiagnosis COVID-19 Ag Test Kit

Wuhan EasyDiagnosis Biomedicine Co., Ltd.

W-Ag03-20

21040101

RTK Antigen

Nasopharyngeal swab (NPS) or Oropharyngeal swab (OPS)

86

City Medic Sdn Bhd

Gmate® COVID-19 Ag Saliva (Professional)

Philosys Co., Ltd.

AG-019

CA10U800

RTK Antigen

Saliva

87

Tri-G Technologies Sdn Bhd

DEEPBLUE COVID-19 (SARS-CoV-2) Antigen Test Kit (Colloidal Gold) Saliva

Anhui Deepblue Medical Technology Co., Ltd, China.

SL030101

20210302

RTK Antigen

Saliva

88

Brighton Occuhealth Services Sdn Bhd

Dia Sure COVID-19 Antigen Rapid Test Device

Azure Biotech Inc., USA

COV-S23

SR2021050036

RTK Antigen

Nasopharyngeal/ oropharyngeal swab (NPS/OPS)

89

TS Diagnostics Sdn Bhd

Forsure COVID-19 Antigen Rapid Test Kit (Oral Fluid)

TS Diagnostics Sdn Bhd, Taman Perindustrian Puchong, Selangor, Malaysia.

FS-CV190F-C30

21060053

RTK Antigen

Saliva

90

LabIVF (M) Sdn Bhd

PCL COVID-19 Ag Gold

PCL, Inc., Korea

COV04S

21025703

RTK Antigen

1. Nasopharyngeal swab (NPS)
2. Saliva

91

Excel Med Sdn Bhd

SARS-CoV-2 Antigen Detection KIt (Colloidal Gold Method)

Xiamen Jiqing Biomedical Technology Co., Ltd., China.

WKI0014

RI21G15CJQ

RTK Antigen

Nasal swab

92

Medical Innovation Ventures Sdn Bhd

Finecare™ 2019-nCoV Antigen Test

Guangzhou Wondfo Biotech Co. Ltd., China

W286

F28615108A

RTK Antigen

Nasopharyngeal/ Oropharyngeal swab

93

Epsilon Medical Devices Sdn Bhd

Virusee® SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)

Genobio Pharmaceutical Co., Ltd, China

VSLFA-20

VS210501

RTK Antigen

Nasopharyngeal swab/ oropharyngeal swab (NPS/OPS)

94

Vitramed (Asia) Sdn Bhd

H&W COVID-19 Salivary Antigen Rapid Test Kit

H & W Biotech Oy, Finland

KSHW2003

S2321033001

RTK Antigen

Saliva

95

Dedikasi Semangat Sdn Bhd

GenSure COVID-19 Antigen Rapid Test Kit (Swab)

Gensure Biotech Inc.,

N/A

P202105036

RTK Antigen

Nasal swab

96

Teda wellness Solutions Sdn Bhd

LYHER® Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)

Hangzhou Laihe Biotech Co. Ltd

303034

2106041

RTK Antigen

Saliva

97

Interscience Sdn Bhd

StrongStep® SARS-CoV-2 Antigen Rapid Test

Nanjing Liming Bio-Products Co. Ltd., P.R.China.

500200

2107006

RTK Antigen

Nasal swab, Saliva

98

Cipla Malaysia Sdn Bhd

Sure Status COVID-19 Antigen Test Card

Premier Medical Corporation Private Limited

SS03- Rapid Diagnostics Test

9FE0521S

RTK Antigen

Nasopharyngeal swab (NPS)

99

Qiagen Biotechnology (M) Sdn Bhd

mö-screen Corona Antigen Test

möLab GmbH, Langenfeld, Germany

230005

2012610

RTK Antigen

Nasal swab, nasopharyngeal swab/ oropharyngeal swab

100

CLA Medical Sdn Bhd

ONE STEP FOR SARS-CoV-2 Antigen (Colloidal Gold) Saliva

Getein Biotech Inc. China

CG2061

6SC216003W

RTK Antigen

Saliva

101

Maximsuria sdn Bhd

COVID-19 Salivary Antigen Rapid Test Kit

WFR Medical Supplies Sdn Bhd

N/A

2021071604

RTK Antigen

Saliva

102

Advance Diagnostic Care Sdn Bhd

SALIVA SARS-CoV (2019-nCoV) Antigen Test Kit (Nanocarbon Assay)

Jiaxing Wisetest Bio-Tech Co. Ltd

WT-1120

2021051801

RTK Antigen

Saliva

103

BA LALAJI Sdn Bhd

Alpine Biomedicals One- Step CoVID- 19 Antigen Rapid Test

Alphine Biomedicals Pvt. Ltd. Haryana, India

N/A

LCOVG-070521

RTK Antigen

Nasal swab

104

Veritas Medical Sdn Bhd

DIAGNOS COVID-19 Antigen Saliva Test Kit (Colloidal Gold)

Nantong Diagnos Biotechnology Co. Ltd, Jiangsu, P.R. China

N/A

202103011

RTK Antigen

Saliva

105

Teda Wellness Solutions Sdn Bhd

LionRun™ SARS-CoV-2 Antigen Rapid Test (Lateral Flow Immunoassay)

Shanghai Liangrun Biomedicine Technology Co., Ltd., Shanghai China.

N/A

X20210406

RTK Antigen

Nasal swab (NS)

106

SPD Scientific (M) Sdn Bhd

Dynamiker SARS-CoV-2 Ag Rapid Test (Saliva)

Dynamiker Biotechnology (Tianjin) Co., Ltd

DNK-2105-1

210710-HW

RTK Antigen

Saliva

107

Hygeia Instruments (M) Sdn Bhd

CLUNGENE® COVID-19 Antigen Rapid Test Cassette

Hangzhou Clongene Biotech. Co. Ltd., China.

ICOV5002-100569/ICOV5002-100596

S202107056

RTK Antigen

Nasal swab

108

Nano Life Quest Sdn Bhd.

Bioteke SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method)

BIOTEKE CORPORATION (WUXI) CO. LTD.

Bioteke SARS-CoV-2 Antigen Test Kit

TC10022021J0425

RTK Antigen

Saliva

109

N.A.Z. Medical Supplies Sdn Bhd

SARS-CoV-2 Antigen Rapid Test (Nasal Swab)

Hangzhou AllTest Biotech Co., Ltd., China

INCP-502-N

ATNCP2060037

RTK Antigen

Nasal swab (NS)

110

Translab (M) Sdn Bhd

Flowflex SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva)

ACON Biotech (Hangzhou) Co., Ltd., China

L031-12515

COV1080048

RTK Antigen

Nasal swab (NS)
Saliva

111

Symbion Asia Sdn Bhd

iHealth Novel Coronavirus Antigen Rapid Test Kit (Saliva)

Symbion Asia Sdn Bhd

Novel Coronavirus Antigen Rapid Test

202108078

RTK Antigen

Saliva

112

Medispec (M) Sdn Bhd

SARS-CoV-2 Antigen Saliva Rapid Test

Qingdao Hightop Biotech Co., Ltd. China

H100S

COV-120818

RTK Antigen

Saliva

113

Robopreneur Sdn Bhd

DIANOBIO Detection Kit for Antigen to SARS-CoV-2 (Colloidal Gold Immunochromatography Method)

Shandong Diano Bio-tech Co., Ltd., China.

DN-JJ-005

20210601

RTK Antigen

Nasal swab (NS)

114

Viga Gemilang Enterprise

Goldsite SARS-CoV-2 Antigen KIt

Goldsite Diagnostic Inc. China.

CG123025

20210415

RTK Antigen

Nasal Swab

115

Axisbio Diagnostics Sdn Bhd

QuickVue® SARS Antigen Test

Quidel Corporation, San Diego, CA,USA

20387

706702

RTK Antigen

Nasal swab

116

LABIVF (M) Sdn Bhd.

RAPIGEN BIOCREDIT COVID-19 Ag One Step SARS-CoV-2 Antigen Rapid Test

Rapigen, INC.

G61RHA20

H073A023DA

RTK Antigen

Nasopharyngeal & Oropharyngeal swab

117

Holista Biotech Sdn Bhd

GeneSign 2019-nCoV Antigen Testing Kit

GeneSign Biotech (Xiamen) Co. Ltd., China.

Not available

2021061601

RTK Antigen

Nasopharyngeal & Oropharyngeal swab

118

CLA Medical Sdn Bhd

Getein Biotech One Step Test for SARS-CoV-2 Antigen

Getein Biotech Inc., Nanjing, China.

CG2061

6SC216014W

RTK Antigen

Nasal swab

119

Genomax Technologies Sdn Bhd

InstaView COVID-19 Antigen

SG Medical Inc., Republic of Korea

R3002

1CCOAG1H02

RTK Antigen

Nasopharyngeal swab/ oropharyngeal

120

SPD Scientific (M) Sdn. Bhd.

DYNAMIKER SARS-CoV-2 AG RAPID TEST

Dynamiker Biotechnology (Tianjin) Co., Ltd.

DNK-1425-1

210705-HW

RTK Antigen

Nasopharyngeal / Oropharyngeal swab

121

Aztec Scientific Sdn. Bhd.

Vazyme SARS-CoV-2 Antigen Detection Kit (Colloidal Gold-Based)

Nanjing Vazyme Medical Technology Co., Ltd.

C8602C

V2021010457C

RTK Antigen

Nasal swab

122

Zuellig Pharma Sdn Bhd

Hopegen COVID-19 Antigen Rapid Test Kit (Colloidal Gold)

Xiamen Hopegen Medical Technology Co., Ltd.

n/a

220210402

RTK Antigen

Nasal swab

123

Karl Mueller Scientific Sdn Bhd

2019-nCoV Ag Saliva Rapid Test Card

Guangzhou Decheng Biotechnology Co., Ltd.

0589C4X020

05821026C

RTK Antigen

Saliva

124

Advance Diagnostic Care Sdn Bhd

SARS-CoV-2 Antigen Test Kit (Colloidal Gold)

Genrui Biotech Inc.

Nasal swab: 52026094

Saliva: 52026095

Nasal swab: 20210813

Saliva: 20210618

RTK Antigen

Nasal and Saliva

125

Apace Medi Health Sdn Bhd

Realy Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Device (Saliva)

Hangzhou Realy Tech Co., Ltd., P.R. China.

K590516D

202108002

RTK Antigen

Saliva

126

JKS Biomedical Sdn Bhd

Tigsun COVID-19 Saliva Antigen Rapid Test

Bei Jing Tigsun Diagnostics Co., Ltd. China

TG-1417

14172101

RTK Antigen

Saliva

127

Almedico Sdn Bhd

StrongStep® SARS-CoV-2 Antigen Rapid Test

Nanjing Liming Bio-Products Co., Ltd., P.R. China

500200

2108001

RTK Antigen

Saliva

128

Chembio Diagnostics Malaysia Sdn Bhd

DPP® SARS-CoV-2 Antigen Test for use with DPP Micro Reader and Micro Reader II

Chembio Diagnostics Systems Inc

65-9571-3; 65-9571-2

SCAG103120/A

RTK Antigen

Nasal swab

129

Biotek Abadi Sdn Bhd

COVID-19 Check-Sal Antigen Rapid Test

Multi G bvba, Belgium

MGGENSAL25

MGCGEN20210308

RTK Antigen

Saliva

130

Translab (M) Sdn Bhd

Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Assay Kit by Colloidal Gold Method (MACCURA)

Maccura Biotechnology Co., Ltd

EIM4102081

521011

RTK Antigen

Nasal swab

131

Biomarketing Services (M) Sdn Bhd

SARS-CoV-2 Antigen Rapid Detection Kit

Shenzhen CAS-Envision Medical Technology Co., Ltd. China

CG201A_HP

P202109001

RTK Antigen

Nasopharyngeal swab (NPS) or Oropharyngeal swab (OPS)

132

LKL Advance Metaltech Sdn Bhd

Medomics SARS-CoV-2 Antigen Test Kit (LFIA)

Jiangsu Medomics Medical Technology Co., Ltd.

SARS-CoV-2 antigen Test Kit (LFIA) 20test/box, 5test/box, 1test/box

MKDS2021033101

RTK Antigen

Nasal swab

133

Axisbio Diagnostics Sdn Bhd

JusChek™ SARS-CoV-2 Antigen Rapid Test (Nasal Swab)

ACRO BIOTECH Inc. USA

ISCO-ACO502

NCP21090099ACO

RTK Antigen

Nasal swab

 

NO

COMPANY NAME

PRODUCT NAME

MANUFACTURER

IDENTIFIER

LOT NUMBER

GENE

DETECTION

SAMPLE TYPE

1

Qiagen Biotechnology Malaysia

QIAstat-Dx Respiratory SARS-CoV-2 Panel

Qiagen N.V

Netherlands

691214

N/A

ORF1ab and E gene

RT-PCR (POCT)

Nasopharyngeal or oropharyngeal swab samples

2

Translab (M) Sdn Bhd

EasyNAT COVID-19

Nucleic Acid Detection Kit

Ustar Biotechnologies (Hangzhou) Co., Ltd., P.R. China

U30003

U20226

20200812

ORF1ab, N and E gene

Rapid Isothermal Amplification (POCT)

Nasopharyngeal or oropharyngeal swab samples

3

SPD Scientific (M) Sdn Bhd

Xpert Xpress SARS-CoV-2

Cepheid, 904 Caribbean Drive, Sunnyvale,

CA, USA

XPRSARS-COV2-10

N/A

N and E gene

RT-PCR (POCT)

Nasopharyngeal or oropharyngeal swab samples

4

Alere Health Sdn Bhd / Abbott Laboratories

ID NOW Covid-19 Assay

Abbott Diagnostics Scarborough, Inc., USA

190-000 (ID Now Covid-19 Test Kit)

190-080 (ID Now Covid-19 External Control Kit)

190-001 &

190-002

RdRp gene

RAPID ISOTHERMAL NEAR

(Rapid Molecular)

Nasopharyngeal or oropharyngeal swab samples

5

Neoscience Sdn Bhd

Sansure Biotech Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing)

Sansure Biotech Inc.

P.R. China

S3102E,
S-Q331A

2020116-3

ORF1ab and N gene

RT-PCR (POCT)

Nasopharyngeal or oropharyngeal swab samples

6

Neopharma Biotech Asia Sdn Bhd

AQ-TOP COVID-19 Rapid Detection Kit PLUS

Seasun Biomaterials Inc. Republic of Korea.

RT-LAMP

CVPR201005

ORF1ab and, RNase P gene

RT-LAMP (POCT)

Nasopharyngeal or oropharyngeal swab samples

7

Neopharma Biotech Asia Sdn Bhd

Isopollo® COVID-19 Detection Kit (real-time)

M monitor Inc.

Republic of Korea

52227

522279239

RdRp and N gene

RT-LAMP (POCT)

Nasopharyngeal or oropharyngeal swab samples

8

Setanding Enterprise Sdn Bhd

CELLSAFE LAMPlex™ RT-qLAMP COVID-19 Detection Assay

CellSafe Co., Ltd.

Republic of Korea

CSCOLAN-100

COLA120120

N gene

RT-qLAMP (Rapid Molecular)

Nasopharyngeal or oropharyngeal swab samples

9

DNA Laboratories Sdn Bhd

Real-time fluorescent RT- PCR kit for detecting 2019- nCoV

BGI Europe A/S Denmark

MFG030015

67202101001

ORF1ab gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

10

Pantasniaga Sdn Bhd

Real-time fluorescent RT-PCR kit for detecting 2019- nCoV

BGI Europe A/S Denmark

MFG030015

67202101001

ORF1ab gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

11

BioD Medica Sdn Bhd

3DMed 2019-nCoVRT- qPCR Detection Kit

3D Biomedicine Science & Technology Co., Ltd.

P.R. China.

3103010011

QP06200301E

ORF1ab, E and N gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

12

Deena System Sdn Bhd

STANDARD M nCoV Real-Time Detection Kit

SD Biosensor

Republic Of Korea

M-NCOV-01

MNCO0120011

ORF1ab (RdRp) and E gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

13

Roche Diagnostics (M) Sdn Bhd

cobas® SARS-CoV-2

cobas® SARS-CoV-2 Control Kit

Roche Diagnostics GmbH Mannheim, Germany

09175431190
09175440190
07002238190

G24743

ORF1ab and E gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

14

Duopharma (M) Sdn Bhd

Real-Q 2019-nCoV Detection Kit

BioSewoom Inc. Republic of Korea

BS7nCoV

580L-009

RdRp and E gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

15

ER Medicare

Toneker Novel coronavirus (SARS-CoV-2) nucleic acid detection kit (PCR fluorescence method)

Anhui Toneker Biotechnology Co., Ltd. P.R. China.

N/A

200506

ORF1ab and N gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

16

Green Health Global Sdn Bhd

Real time RT PCR Detection Kit For 2019 nCoV

Hangzhou DIAN Biotechnology Co Ltd. P.R.  China

N/A

200427011

ORF1ab and E gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

17

Biomarketing Services (M) Sdn Bhd

Liferiver Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit

Shanghai ZJ Bio-tech Co., Ltd.

P.R. China.

RR-0479-02

P20200401

ORF1ab, N and E gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

18

Medicara Sdn Bhd

XABT Multiple Real-Time PCR Kit for Detection of 2019-nCoV

Beijing Applied Biological Technologies Co., Ltd. P.R.China

CT8223-48T

20200403

ORF1ab, N and E gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

19

Emergo Malaysia Sdn Bhd

AccuraDTectTM SARS- CoV-2 RT-qPCR Kit

Genomictree Inc.

Republic of Korea

GT-CV2-100

GT-CV2-200402

N and RNase P gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

20

HWG Consortium Sdn Bhd

eDiagnosis COVID-19 (SARS-CoV-2) Nucleic Acid Test Kit

Wuhan EasyDiagnosis Biomedicine Co.,Ltd.

P.R. China

N/A

200701HW

ORF1ab and N gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

21

Premier Diagnostics Sdn. Bhd.

eDiagnosis COVID-19 (SARS-CoV-2) Nucleic Acid Test Kit

Wuhan EasyDiagnosis Biomedicine Co., Ltd.
Room 3 & 4, 2nd Floor, Bldg 25, Phase 3.1

N/A

200701HW

ORF1ab and N gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

22

Klinik Kuchai (Dr Kaarthikk Gaanth A/L Kanniah)

MoleculTech Real-Time COVID-19

YD Diagnostics Corp,
Republic of Korea

N/A

M2042011

RdRp and E gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

23

Biomerieux Malaysia Sdn Bhd

BioFire RP 2.1 plus

Biofire Defence,

Utah, USA

423740

LOT 1324720

S and M gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

24

Neoscience Sdn Bhd

Allplex™ SARS-CoV-2

Seegene Inc,

Republic of Korea

RV10247Y & RV10248X

N/A

E, RdRP, S and N gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

25

Neoscience Sdn Bhd

Allplex™ 2019-nCoV Assay

Seegene Inc,

Republic of Korea

RP10244Y & RP10243X

RP4520HC4

E, RdRP and N gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

26

Biomarketing Services (M) Sdn Bhd

TaqPath™ COVID-19 CE-IVD RT-PCR Kit (Cat.No: A48067)

Life Technologies Corporation

CA, USA

A48067

2003009

ORF1ab, S and N gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

27

Siemens Healthcare Sdn Bhd

FTD SARS-CoV-2

Fast Track Diagnostics Germany

REF: FTD-114-96
SMN: 11416284

SC20-96-11

ORF1ab and N gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

28

Malaysian Diagnostics Corporation Sdn Bhd

GeneFirst COVID-19 Nucleic Acid Diagnostic Kit

GeneFirst Limited, United Kingdom

COVID-19

100

ORF1ab and N gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

29

Biomarketing Services (M) Sdn Bhd

TaqPath™ COVID-19 Combo Kit

(Cat No.: A47814)

Life Technologies Corporation, USA.

A47814

2003009

ORF1ab, N and S gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

30

Interscience Sdn Bhd

Viasure Sars-CoV-2 Real Time PCR Detection kit

CerTest Biotec SL. Spain

VS-NC0206L

VS-NCO206H

VS-NCO212L

VS-NCO212H

VS-NCO213L

VS-NCO213H

NCO212L-084

ORF1ab and N gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

31

Med Save Assistance Sdn Bhd

Fosun 2019-nCoV qPCR

Shanghai Fosun Long March Medical Science Co., Ltd.

P.R. China

N/A

20200406

ORF1ab, N and E gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

32

Tri-G Technologies Sdn Bhd

Fosun 2019-nCoV qPCR

Shanghai Fosun Long March Medical Science Co., Ltd.
P.R. China

PCSYHF02-a (48 tests/kit); PCSYHF03-a (96 tests/kit).

20200414

ORF1ab, N and E gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

33

MPCN Dot Com Sdn Bhd

Fosun 2019-nCoV qPCR

Shanghai Fosun Long March Medical Science Co., Ltd.

P.R. China

N/A

E20200415

ORF1ab, N and E gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

34

Premier Diagnostics Sdn Bhd

LabGun COVID-19 RT- PCR Kit

LabGenomics Co.,Ltd. Republic of Korea

CV9032B

CVR20E001

RdRp and E gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

35

Medical Innovations Ventures Sdn Bhd

GenoAmp® Real-Time RT-PCR SARS-CoV-2

Medical Innovation Ventures Sdn. Bhd.

Penang, Malaysia.

GRA2033

GRA203320OCT06

RdRp, S and N gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

36

Neopharma Biotech Asia Sdn Bhd

MolecuTech® Real-Time COVID-19

YD Diagnostics Corp. Republic of Korea

MolecuTech®

M2042011

RdRp and E gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

37

Key Alliance Sdn Bhd

WellsBio CareGENE N- CoV RT-PCR kit

Wells Bio, Inc

Republic of Korea

MCD-N05082

MNC20F291

RdRp and E gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

38

Translab (M) Sdn Bhd

Maccura SARS-CoV-2 Fluorescent PCR

Maccura Biotechnology Co. Ltd. P.R. China

EGN7101109, EGN7103109

1020561

ORF1ab, E and N gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

39

My Big Sdn Bhd

Genefinder Covid-19 Plus RealAmp Kit

Osang Healthcare Co. Ltd.

Republic of Korea

IFMR-45

2003-R45-27

RdRP, E and N gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

40

Trust Diagnostics (M) Sdn Bhd

GB SARS-CoV-2 Real- Time RT-PCR

General Biologicals Corporation, Taiwan

4PCO042E

PVT60A07

ORF1ab and E gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

41

Ambang Sihat Sdn Bhd

1copyTM COVID-19 qPCR Multi Kit

1drop Inc.

Republic of Korea

M22MD100M

M220K2400

E and RdRp gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

42

Axisbio Diagnostics Sdn Bhd

Labsystems Diagnostics Covid-19 Real-Time PCR Kit

Labsystems Diagnostics Oy Vantaa, Finland

8100513

312RK1-1

ORF1ab, E and N gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

43

Medical Innovations Ventures Sdn Bhd

GenoAmp® Real-Time RT-PCR Flu A/ Flu B/SARS-CoV-2/MERS-CoV

Medical Innovation Ventures Sdn. Bhd.
Penang, Malaysia.

GRA2032

GRA203220DEC10

RdRp, S and N gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

44

Canvio Sdn Bhd

iAMP® COVID-19 Detection Kit

Atila BioSystems, Inc. CA, USA

iAMP-COVID19-100

COVID20200506

ORF1ab and N gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

45

Interscience Sdn Bhd

Alinity m SARS-CoV-2 AMP kit
Alinity m SARS-CoV-2 CTRL kit
Alinity m SARS-CoV-2 application Specification File Ver 2.00

Abbott Molecular Inc. USA

09N78-090,
09N78-01B

510732

RdRp and N gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

46

Medical Innovations Ventures Sdn Bhd

RESOLUTE 2.0 SARS-CoV-2 Direct Detection Kit

AMT Pte. Ltd.
Singapore

CKFG0002

CK02000026

E, N and RNase P gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

47

Science Vision Sdn Bhd

AccuPower SARS-CoV-2 Multiplex Real-Time RT-PCR Kit

Bioneer Corporation

Republic of Korea

SCVM-2112

200931L

E, RdRp and N gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

48

Biomerieux Malaysia Sdn Bhd

BioFire® Respiratory Panel 2.1 (RP2.1)

Biofire Defence, USA

423738

423738

S gene and M gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

49

ADT Biotech Sdn Bhd

LyteStar™ 2019-nCoV PCR Kit 2.0

ADT Biotech Sdn Bhd, Malaysia

888003

N/A

E gene and RdRP gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

50

UAGB Biotech Sdn Bhd

Vazyme 2019-Novel Coronavirus (2019-nCoV) Triplex RT-qPCR Detection Kit

Nanjing Vazyme Medical Technology Co., Ltd.
Nanjing, P.R. China

CD302

7E480J0

ORF1ab, N and RNase P gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

51

Pantasniaga Sdn Bhd

Real-time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2

BGI Europe A/S
Denmark

MFG030015

67202101001

ORF1ab, and N gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

52

SPD Scientific (M) Sdn Bhd

Genedrive® 96 SARS-CoV-2 Kit

Genedrive Diagnostics Ltd. 48 Grafton Street, Manchester M13 9XX United Kingdom

D-COV2-01-LPC
ID-COV2-01-FPC
ID-COV2-01-BPC

17161082BP

E and N gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

53

Perkin Elmer Sdn Bhd

PerkinElmer® 96 SARS-CoV-2 kit

Suzhou SYM-BIO LifeScience Co.,Ltd. Jiangsu Province, China

COVID-18-PCR-AUS-C
SY609

AZ 20200812

ORF1ab gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

54

Wija Pharma Sdn Bhd

Zybio SARS-CoV-2 Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method)

Zybio Inc. China

CoV2-32

5102005

ORF1ab, and N gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

55

DW LABS Sdn Bhd

Diagnovital SARS-CoV-2 Multiplex Real Time PCR

RTA Laboratuvarlari Biyolojik Urunler

09072025

09072050

09072100

CP2077221

N gene ORF1 ab gene, RNAse P

RT-PCR

Nasopharyngeal swabs or oropharyngeal swabs

56

Almedico Sdn Bhd

WizDx™ COVID-19 CrystalMix PCR Kit

Wizbiosolutions Inc. South Korea

DX1203A (96 Tests/kit),

eQ162C (Portable PCR Machine)

5B1220-01

RdRp and E gene

RT-PCR

Nasopharyngeal (NPS) combined with Oropharyngeal (OPS) swabs

57

Health4u Solutions Sdn Bhd

Oxsed RaViD Direct SARS-CoV-2 Test

Oxford MEStar Ltd. Oxford, United Kingdom

RaVID-OQ8

GD201028-T01

-

RT-LAMP

Nasopharyngeal swab & Oropharyngeal swabs

58

Interscience Sdn Bhd

VIASURE SARS-CoV-2, Flu & RSV Real Time PCR Detection Kit

CerTest Biotec, S.L., Zaragoza, Spain

VS-CFR112L

CFR112L-005

N gene, RNAse P

RT-PCR

Nasopharyngeal swab & Oropharyngeal swabs

59

Medical Innovation Ventures Sdn Bhd

GenoAmp® Real-Time RT-PCR COVID-19

Medical Innovation Ventures Sdn Bhd., Penang, Malaysia

Product code: GRA2035

GRA203521MAY03

RdRp gene, S gene, and N genes

RT-PCR

Nasopharyngeal swab & Oropharyngeal swabs

60

Interscience Sdn Bhd

Abbott RealTime SARS-CoV-2 Amplification Reagent KIt, Abbott RealTime SARS-CoV-2 Control Kit

Abott Molecular INC, USA

09N77-090, 09N77-080, 09N77-001

514504

RdRp gene, N gene

RT-PCR

Nasopharyngeal swab & Oropharyngeal swabs

61

SPD Scientific (M) Sdn Bhd

SARS-CoV-2 Elite MGB® Kit

ElitechGrop S. p. A. C. so Torino, Italy

RTS170ING

U1020-070

RdRp gene, ORF8 gene

RT-PCR

Nasopharyngeal swab & Oropharyngeal swabs

62

Trust Diagnostics Sdn Bhd

SARS-CoV-2 Test Kit (Real-time PCR) Automatic Medical PCR Analysis System Sanity 2.0

Xiamen Zeesan Biotech Co., Ltd, China

801305 (contains reagent for 12 tests)

21022401

ORF1ab gene

N gene

RNase

RT-PCR

Nasopharyngeal swab & Oropharyngeal swabs

63

Edaran Medicaltech (M) Sdn Bhd

Ezplex SARS-CoV-2 G Kit

SML Genetree Co, Ltd, Korea

GNT2011-1

NCVA02EI002

RdRp gene

N gene

RT-PCR

Nasopharyngeal swab & Oropharyngeal swab

64

Neoscience Sdn Bhd

Allplex™ SARS-CoV-2 Master Assay

Seegene Inc, Republic of Korea

RV10284X
RV10285Y

RVA321C01

E gene, RdRP gene, S gene, and N gene) and variants of S gene (HV69/70del, Y144del, E484K, N501Y, P681H)

RT-PCR

Extracted RNA from samples confirmed for COVID-19 and genotyped using gold standard whole genome sequencing

65

Neoscience Sdn Bhd

Allplex™ SARS-CoV-2 Variants I Assay

Seegene Inc, Republic of Korea

RV10286X, RV10287Y

RVA521C01

Spike protein mutations(E484,N501Y, and HV69/70 deletion) and RdRP gene

RT-PCR

Extracted RNA from samples confirmed for COVID-19 and genotyped using gold standard whole genome sequencing

66

Neoscience Sdn Bhd

Allplex SARS-CoV-2/FluA/FluB/RSV Assay

Seegene Inc, Republic of Korea

RV10259X, RV10260Y

RV19320J08

S gene, RdRp gene, N gene

Multiplex real-time one-step RT-PCR

RNA extracted material from nasopharyngeal swab(NPS) combined with Oropharyngeal swab (OPS)

67

Numeric Diagnostics (M) Sdn Bhd

MiRXES Fortitude SARS-CoV-2 and Flu A/B Test

MiRXES Pte. Ltd. Singapore

FGS0022R

D14-21006

ORF1ab gene, N gene

RT-PCR

Nasopharyngeal swab & Oropharyngeal swab

68

Hyperion Sdn Bhd

TEPAT 1.0 SARS-CoV-2 Multiplex RT-PCR Kit

CELLBAE PTE LTD, 31 Bioplolis Way The Nanos, Singapore.

TP-001-01

P202009-C10

RdRp gene, M gene

RT-PCR

Nasopharyngeal swab(NPS) & Oropharyngeal swab (OPS)

69

Pharmaniaga Marketing Sdn Bhd

LANDWIND Novel Coronavirus (2019-nCoV) Nucleic acid Diagnostic Kit

Shenzhen Landwind Biotechnology Co., Ltd., Guangdong Province.

N/A

192410002

ORF1ab gene, N gene

PCR- Fluorescence Probing

Nasopharyngeal swab(NPS) & Oropharyngeal swab (OPS)

70

Next Gene Scientific Sdn Bhd

abTES COVID-19 qPCR I Kit

AITbiotech Pte Ltd 25, Pandan Crescent #05-15, TIC TECH Centre, Singapore 128477

#300141, #300142 #800811_C

L141-261

Orf1a gene

RT-PCR

Oropharyngeal & nasopharyngeal swab

71

Neoscience Sdn Bhd

Allplex SARS-CoV-2 Assay (Extraction NIMBUS)

Seegene Inc. Taewon Bldg., 91 Ogeum-ro, Songpa-gu, Seoul, Republic of Korea 05549

RV10247Y & RV10248X

RV9121C22

Egene, RdRP gene, S gene, N gene

RT-PCR

Saliva

72

BioD Medica Sdn Bhd

ANDiS FAST SARS-CoV-2 RT-qPCR Detection Kit

3D Biomedicine Science & Technology Co., Ltd. China.

3103010069

QP08210401E1

ORF1ab gene, N gene, E gene

RT-PCR
(POCT)

Nasopharyngeal swab (NPS) and Oropharyngeal swab (OPS)

73

Ewis Sdn Bhd

Geneme® FRANKD SARS-CoV-2 Isothermal Amplification Detection Kit

Geneme Sp. I ul, Poland.

FRAND Sample Collection Kit (5373436448)
FRANKD (5373437481)

88161120001

S gene

RT-PCR
(POCT)

Nasopharyngeal swab (NPS) and Oropharyngeal swab (OPS)

74

My-Sutera Sdn Bhd

GENEDIA W COVID-19 Real time RT-PCR

Green Cross Medical Science Corp., Republic of Korea

759A

759A2003

RdRP, E,N,S gene

RT-PCR

Nasopharyngeal swab (NPS) and Oropharyngeal swab (OPS)

75

Science Vision Sdn Bhd

BioTNS COVID-19 RT-PCR PNA Kit

BioTNS TNS Co. Ltd., Korea.

TD1100

BCCA

RdRp gene, N gene

RT-PCR

Nasopharyngeal swab (NPS) and Oropharyngeal swab (OPS)

76

Neoscience Sdn Bhd

Agilent SARS-CoV-2 qRT-PCR Dx Kit

Agilent Technologies, Inc. 1834, Hwy 71 West Cedar Creek, TX 78612. USA.

Catalogue No.: K1180A, K1180B, K1180C

6609769

N1 gene and N2 gene

RT-PCR

Oropharyngeal and Nasopharyngeal swab

77

Monitorbio Group Sdn Bhd

LIUR Test Saliva- Based COVID-19 PCR Test

MonitorBio Group Sdn Bhd

LIUR

MBG 2021005

N gene and S gene

RT-PCR

Saliva

78

Tri-G Technologies Sdn Bhd

LabGun™ COVID-19 Exofast RT-PCR Kit

LabGenomics Co. Ltd., Republic of Korea.

CV9034B

CVF21E004

RdRp gene, N gene

RT-PCR

Oropharyngeal and Nasopharyngeal swab

79

Qiagen Biotechnology Malaysia Sdn Bhd

ARTUS® SARS-CoV-2 Prep&Amp
UM Kit

Qiagen GmbH, Germany

Reaction :
1) 768, Catalog : 4511460
2) 3072, Catalog : 4511469

169028102

N1 gene and N2 gene

RT-PCR (POCT)

1. Nasopharyngeal (NPS)/ Oropharyngeal swab (OPS)
2. Nasal swab (NS)

80

Matrioux (M) Sdn Bhd

Novel Coronavirus (2019-nCoV) Real Time Multiplex RT-PCR Kit (Detection for 3 Genes)

Shanghai ZJ Bio-Tech Co., Ltd., China

RR-0479-02

P20200401

ORF1ab, N and E gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

81

Roche Diagnostics (M) Sdn Bhd

COBAS SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the COBAS LIAT System

Roche Molecular System, Inc.

P/N: 09211101190 (20 tests / kit)

10419Y

-

RT-PCR (POCT)

Nasal, nasopharyngeal and oropharyngeal swab

82

Wija Pharma Sdn Bhd

iONEBIO iLAMP Novel-CoV19 Detetion Kit

iONEBIO Co., Ltd Korea

REF. : CoV19-iLAMP

KLJun09A10000

-

RT-LAMP

Nasopharyngeal (NPS) and Oropharyngeal swab (OPS)

83

Simson Trading Sdn Bhd

Fosun 2019-nCoV qPCR

Shanghai Fosun Long March Medical Science Co., Ltd.

PCSYHF02-a (48 tests/kit);

PCSYHF03-a (96 tests/kit).

N/A

ORF1ab, N and E gene

RT-PCR

Nasopharyngeal or oropharyngeal swab samples

84

Translab (M) Sdn Bhd

EasyNAT Novel Coronavirus (2019-nCoV) RNA (Isothermal Amplification- Real Time Fluorescence Assay)

Ustar Biotechnologies (Hangzhou) Ltd, China.

Ref. : U20223

20210615

ORF1ab and N gene

RT-LAMP POCT

Nasopharyngeal (NPS) and Oropharyngeal swab (OPS)

85

Next Gene Scientific Sdn Bhd

NEXdia™ 2019-nCoV Detection KIt

Genes Laboratories, Republic of Korea

Model name: NexD-C1DTH (100 tests/kit)

V159L1

RdRP gene, N gene, E gene

RT-PCR

Nasopharyngeal (NPS) and Oropharyngeal swab (OPS)

86

Asia Coding Centre Sdn Bhd

VERI-Q PCR 316 Coronavirus Disease 2019 (COVID-19) Detection Kit nCoV-QS

MiCo Biomed., Ltd., Korea.

7K105

M224221DY1SA

ORF3a gene, N gene

Rapid Molecular

Nasopharyngeal (NPS)/ Oropharyngeal swab (NPS/OPS)

87

MyGenome Sdn Bhd.

Detection Kit for 2019-nCoV RNA (Multiple RT-PCR Fluorescence Probing) (Lyophilised)

Guangdong Huayin Medicine Science Co., Ltd

HY06112

20200401

ORF1 a/b gene, N gene, and S gene

RT-PCR

Oropharyngeal swab

88

INTERSCIENCE SDN BHD

StrongStep®
Novel Coronavirus (SARS-CoV-2)
Multiplex Real-Time PCR Kit

Nanjing Liming Bio-products Co. Ltd,China

500190

62104001A

N gene, E gene and ORF1ab gene

RT-PCR

Nasopharyngeal (NPS) and Oropharyngeal swab (OPS)

89

TRI-G Technologies Sdn Bhd

1copyTM COVID-19 qPCR Triplex Kit

1 drop Inc. Korea

M23MD100T

M231B2400

N gene, E gene

RT-PCR

Nasopharyngeal swab (NPS) and Oropharyngeal swab (OPS)

90

Dedikasi Semangat (M) Sdn Bhd

BioGerm Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing)

Shanghai BioGerm Medical Technology Co., Ltd China.

n/a

20210521B

ORF1ab and N gene

RT-PCR

Nasopharyngeal & Oropharyngeal swab

91

Neopharma Biotech Asia Sdn Bhd

SSf-COVID-19

Seasun Biomaterials Inc., Korea

SS-9970

AH-021005

RdRp gene, E gene

RT-PCR

Nasopharyngeal swab and Oropharyngeal swab

92

Almedico Sdn Bhd

StrongStep® Novel Coronavirus (SARS-CoV-2) Multiplex Reat-Time PCR Kit

Nanjing Liming Bio-products Co., Ltd.

500190

62104001A

N gene, E gene and ORF1ab gene

RT-PCR

Nasopharyngeal swab (NPS) combined with oropharyngeal swab (OPS)

93

Omega Tech Facilities Sdn Bhd

SARS-CoV-2 RT PCR Multiplex Diagnostic Kit

HA TECH PTY Ltd. Sydney Australia

NAT-01

NAT-01-210901

N gene, E gene and ORF1ab gene

RT-PCR

Nasopharyngeal swab (NPS) & Oropharyngeal swab (OPS)

 

NO

COMPANY NAME

PRODUCT NAME

MANUFACTURER

IDENTIFIER

LOT NUMBER

DETECTION

SAMPLE TYPE

1

MY E.G. Services Berhad

Diagnostic Kit for Antibody IgM/IgG of Novel Coronavirus COVID-19

Shanghai Liangrun Biomedicine Technology Co., Ltd.

P.R. China

N/A

N/A

RTK

Antibody

Serum

2

Science Valley Sdn Bhd

STANDARD Q COVID-19 IgM/IgG Combo

SD Biosensor, Inc.

Republic of Korea

Ref. No: Q-NCOV-01C
Cat. No: 09COV50G

BQC05020001

COD220001

RTK Antibody

Serum

3

Roche Diagnostics (M) Sdn Bhd

Standard Q SARS-CoV-2 Rapid Antibody Test

SD Biosensor, Inc.

Republic of Korea

9901-NCOV-02C

QCO5020029A

RTK Antibody

Serum

4

Premier Diagnostics Sdn Bhd

Asan Easy Test COVID-19 IgG/IgM

Asan Pharmaceutical Co., Ltd. Republic of Korea

AM3471-K

EIX002

RTK Antibody

Serum

5

ER Medicare

Maccura SARS-CoV-2 Antibody Assay Kit

Maccura Biotechnology Co., Ltd. P.R. China.

1M4102079

320081

RTK Antibody

Serum

6

Malaysian Diagnostics Corporation Sdn Bhd

SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold Method)

ZYbio Inc.

P.R. China

N/A

H200500

RTK Antibody

Serum

7

Vitramed (Asia) Sdn Bhd

careUS™ COVID-19 IgM IgG

Wells Bio Inc.

Republic of Korea

BR034A

RCO20E251

RTK Antibody

Serum

8

Green Health Global Sdn Bhd

Covid-19 IgG/IgM Rapid Test Cassette (Whole blood/Serum/Plasma)

Zhejiang Orient Gene Biotech Co Ltd. P.R. China

N/A

2003242

RTK Antibody

Serum

9

VQM Marketing Sdn Bhd

2019-nCoV IgG/IgM Rapid Test Cassette

Hangzhou AllTest Biotech Co. Ltd. P.R. China

INCP-402

NCP20050072

RTK Antibody

Serum

10

Acutest System (M) Sdn Bhd

Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test

Cellex Inc.

USA

N/A

ZCFX20200609WI5513C-3

RTK Antibody

Serum

11

Pall Thai Medical Sdn Bhd

Covid-19 Rapid IgG/IgM Combined Antibody Pre-Screening Kit

Spring Healthcare Services AG Switzerland

ERCSS05310

ERCSSO5310

RTK Antibody

Serum

12

Tri-G Technologies Sdn Bhd

Rightsign Covid-19 IgG/IgM Rapid Test Cassette

Hangzhoou Biotest Biotech Co., Ltd. P.R.China

N/A

COV2008002-S

RTK Antibody

Serum

13

DKSH Technology Sdn Bhd

Biolidics 2019-nCoV IgG/IgM Antibody Detection Kit

Biolidics Ltd,

Singapore

CBB-F015016-B1

V5020042652B

RTK Antibody

Serum

14

Merlin Medic Sdn Bhd

Covid-19 lgG/lgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

HEALGEN Scientific Limited Liability Company,

USA.

GCCOV-402a

2006084

RTK Antibody

Serum

15

Medical Innovation Ventures Sdn.
Bhd. Penang, Malaysia

ProDetect® COVID-19 IgG/IgM Rapid Test (Dipstick)

Medical Innovation Ventures Sdn. Bhd.

Penang, Malaysia

PR-CVD

PRCVD20OCT16G

RTK Antibody

Serum

16

Medical Innovation Ventures Sdn. Bhd. Penang, Malaysia

ProDetect® COVID-19 IgG/IgM Rapid Test (cassette)

Medical Innovation Ventures Sdn. Bhd.

Penang, Malaysia

PR-CVDC

RRCVDC20NOVOV03

RTK Antibody

Serum

17

Translab (M) Sdn Bhd

NADAL® COVID-19 IgG/IgM Test (test cassette)

nal von minden GmbH
Carl-Zeiss-Strasse 12 • 47445 Moers • Germany

243001N

174159

RTK Antibody

Serum

18

Exza Medical Sdn Bhd

Hightop SARS-CoV-2 IgM/IgG Antibody Rapid Test

Qingdao Hightop Biotech Co., Ltd, China

SARS-CoV-2 IgM/IgG Antibody Rapid Test (40 tests/kit)

COV1252009C

RTK Antibody

Serum

19

Reszon Diagnostics International Sdn. Bhd.
Selangor, Malaysia

Reszon COVID 19 Rapid IgG/IgM Test

Reszon Diagnostics International Sdn. Bhd.
Selangor, Malaysia

RCV-RD0101,
RCV-RD0101B

20201101

RTK Antibody

Serum

20

Siemens Healthcare Sdn Bhd

ADVIA Centaur® SARS-CoV-2 Total (COV2T)

ADVIA Centaur® SARS-CoV-2 Total Quality Control (COV2T QC)

Siemens Healthcare Diagnostics Inc. USA

Ref: 11206710 (100 test//kit)
Ref: 11206922 (500 test/kit)

709004

Antibody Assay

Serum

21

Siemens Healthcare Sdn Bhd

Atellica® IM SARS-CoV-2 Total (COV2T)

Atellica® IM SARS-CoV-2 Total Quality Control (COV2T QC)

Siemens Healthcare Diagnostics Inc. USA

Ref: 11206711 (100 test)
Ref: 11206923 (500 test)

709004

Antibody Assay

Serum

22

Roche Diagnostics (M) Sdn Bhd

Elecsys® Anti-SARS-CoV-2 CalSet Anti-SARS-CoV-2 S PreciControl Anti-SARS-CoV-2 S

Roche Diagnostics GmbH, Mannheim, Germany

09203095190

92030955500

Antibody Assay

Serum

23

Abbott Laboratories (M) Sdn Bhd

SARS-CoV-2 IgG Reagent Kit SARS-CoV-2 IgG Calibrator Kit SARS-CoV-2 IgG Control Kit

Abbott Ireland,

Diagnostics Division, Sligo, Ireland.

SARS-CoV-2 IgG Reagent Kit (List No. 6R90-22)
SARS-CoV-2 IgG Reagent Kit (List No. 6R90-32)
SARS-CoV-2 IgG Calibrator Kit (List No. 6R90-02)
SARS-CoV-2 IgG Control Kit (List No. 6R90-12)

18099FN00

Antibody Assay

Serum

24

Beckman Coulter Malaysia

Access SARS-CoV-2 IgG

Access SARS-CoV-2 IgG Calibrator Access SARS-CoV-2 IgG QC:QC (Quality Control) materials

Beckman Coulter, Inc.

CA U.S.A.

C58961

C58963 C58964

971197

Antibody Assay

Serum

25

Bio Universal Med Sdn Bhd

ImmuSAFE™ COVID+ Biochip Test

Applied Microarrays, Inc. USA

39508H

N/A

Antibody MicroArray

Serum

26

DiagnostiCARE Sdn Bhd

VITROS Immunodiagnostic Products Anti-SARS-2 Total Reagent Pack
VITROS Immunodiagnostic Products Anti-SARS-2 Total Control
VITROS Immunodiagnostic Products Anti-SARS-2 Total Calibrator

Ortho-Clinical Diagnostics, Inc.

New York

6199922

6199923

6199924

240

Antibody Assay

Serum

27

DiagnostiCARE Sdn Bhd

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG

Ortho-Clinical Diagnostics
United Kingdom

6199919,
6199920,
6199921

160

Antibody Assay

Serum

28

Roche Diagnostics (M) Sdn Bhd

Elecsys Anti-SARS-CoV-2

Roche Diagnostics GmbH, Mannheim, Germany

9203095190

9203095500

Antibody Assay

Serum

29

Siemens Healthcare Sdn Bhd

ADVIA Centaur® SARS-CoV-2 IgG (sCOVG)

Siemens Healthcare Diagnostics Inc. Tarrytown, NY USA

11207376-100test
11207377-500test

4058001

Antibody Assay

Serum

30

Siemens Healthcare Sdn Bhd

Atellica® IM SARS-CoV-2 IgG (sCOVG)

Siemens Healthcare Diagnostics Inc. Tarrytown, NY USA

Ref: 11207386 (100 test/kit)
Ref:11207387 (500 test/kit)

4051001

Antibody Assay

Serum

31

Premier Diagnostics Sdn Bhd

WANTAI SARS-COV-2 Ab ELISA (Total)

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd,  Beijing, China

ws-1096

NCOA20201001

Antibody Assay

Serum

32

Premier Diagnostics Sdn Bhd

COVID-19 IgG/IgM Rapid Test Device (Whole Blood/ Serum/ Plasma)

Assure Tech. (Hangzhou) Co., Ltd, China

COV-W23M

SR2021010037

RTK Antibody

Serum

33

Chemopharma Sdn Bhd

Anti-SARS-CoV-2 ELISA (IgG)

Euroimmun Medizinische Labordiagnostika AG, Deutchland

EI 2606-9601G

E201029AW

Antibody Assay

Serum

34

Chimera-Tech Sdn Bhd

Neutralizing Antibody of SARS-CoV-2 Test

Anbio (Xiamen) Biotechnology Co., Ltd

A6021501

20201221601

Neutralizing Antibody Assay

Serum

35

Abbott Laboratories (M) Sdn Bhd

SARS-CoV-2 IgM (Architect i system)

Abott Ireland, Ireland

SARS-CoV-2 IgM Reagent Kit (List No. 6R87-22) 100 tests, (List No. 6R87-32) 500 tests
SARS-CoV-2 IgM Calibrator Kit (List No. 6R87-02)
SARS-CoV-2 IgM Control Kit (List No. 6R87-12)

23537FN00

Antibody Assay

Serum

36

Premier Diagnostics Sdn Bhd

E Diagnosis COVID-19(SARS-CoV-2) IgM/IgG Antibody Test Kit

Wuhan EasyDiagnosis Biomedicine Co., Ltd. P.R. China

2. 002932

20070101

RTK Antibody

Serum

37

Poliklinik Plaza Damansara

E Diagnosis COVID-19(SARS-CoV-2) IgM/IgG Antibody Test Kit

Wuhan EasyDiagnosis Biomedicine Co., Ltd. P.R. China

2. 002932

20030401

RTK Antibody

Serum

38

Azion Healthcare Sdn Bhd

Bel TEST-It! SARS-CoV-2 IgM/IgG rapid test

PharmACT GmbH,
Berlin, Deutchland

CV.10.01

CV.10.10

CV.10.100

20200418001

RTK Antibody

Serum

39

Biomarketing Services (M) Sdn Bhd

MAGLUMI™ 2019-nCoV IgG (CLIA)

Shenzen New Industries Biomedical Engineering Co., Ltd, China.

130219015M

2722001301

RTK Antibody

Serum

40

Biomarketing Services (M) Sdn Bhd

MAGLUMI™ 2019-nCoV IgM (CLIA)

Shenzen New Industries Biomedical Engineering Co., Ltd, China.

130219016M

2712001501

RTK Antibody

Serum

41

Pharmaniaga Marketing Sdn Bhd

BIOTRON COVID-19 IgG/IgM Rapid Test Kit (Immuno-Chromatography)

Guangzhou Biotron Technology Co., Ltd, China

N/A

A3011062820

RTK Antibody

Serum

42

Chimera-Tech Sdn Bhd

MP Diagnostic ASSURE SARS-CoV-2 IgG/IgM Rapid Test

MP Biomedicals Asia Pacific Pte. Ltd, Singapore

43140-020

DC1001

RTK Antibody

Serum

43

Translab (M) Sdn Bhd

Maccura SARS-CoV-2 IgG (CLIA)

Maccura Biotechnology Co., Ltd, China

EIM4407014

920061

Antibody Assay

Serum

44

Alere Health Sdn Bhd

Panbio™COVID-19 IgG/IgM Rapid Test Device (Figerstick Whole Blood/ Venous Whole Blood/ Serum/Plasma)

Abbott Rapid Diagnostics Jena GmbH, Germany

ICO-T402

COV0082022

RTK Antibody

Serum

45

Chemopharm Sdn Bhd

Mindray SARS-CoV-2 IgM (CLIA)

Shenzhen Mindray Bio-Medical Electronics Co., Ltd, China

105-019873-00

2020050303

Antibody

Serum

46

Chemopharm Sdn Bhd

Mindray SARS-CoV-2 IgG (CLIA)

Shenzhen Mindray Bio-Medical Electronics Co., Ltd, China

105-019883-00

2020050303

Antibody

Serum

47

Beckman Coulter
Malaysia Sdn Bhd

Access SARS-CoV-2 IgM

Beckman Coulter, Inc, Brea, CA, USA

C58957

C58958

C58959

971288

Antibody Assay

Serum

48

Holista Biotech Sdn Bhd

HECIN 2019 n-CoV IgM/IgG Antibody Test Kit (Colloidal gold method)

Guangdong Hecin Scientific, Inc., China

NL-CA002-2020-54429

20201101

RTK Antibody

Serum

49

Siemens Healthcare Sdn Bhd

Dimension EXL SARS‑CoV‑2 Total Antibody Assay

Siemens Healthcare Diagnostics Inc., USA

REF: RF812, SMN:11417412 REF: KC813, SMN:11417413 REF: KC815, SMN:11417415

EA1253

Antibody Assay

Serum

50

Chemopharm Sdn Bhd

BIOEASY 2019-Novel Coronavirus (2019-nCoV) IgG/IgM GICA Rapid Test (Colloidal Gold)

Shenzhen Bioeasy

Biotechnology Co., Ltd,

People's Republic of China

N/A

2003N106

RTK Antibody

Serum

51

Abbott Laboratories (M) Sdn Bhd

Alinity SARS-CoV-2 IgG (also referred to as SARSCoV-2 IgG) SARS-CoV-2 IgG Calibrator Kit (also referred to as CoV-2 IgG Cal) SARS-CoV-2 IgG Control Kit (also referred to as CoV-2 IgG Ctrls)

Abbott Ireland Diagnostics

Division Finisklin Business

Park Sligo, Ireland

06R9022

06R9032

06R9002

06R9012

25448FN00

Antibody

Assay

Serum

52

Abbott Laboratories (M) Sdn Bhd

Alinity SARS-CoV-2 IgM SARS-CoV-2 IgM Calibrator Kit

SARS-CoV-2 IgM Control

Abbott Ireland Diagnostics Division Finisklin Business Park Sligo, Ireland

06R9122

06R9132

06R9112

25048FN00

Antibody

Assay

Serum

53

Translab (M) Sdn. Bhd.

Maccura SARS-CoV-2 IgM/IgG Antibody Assay Kit by Colloidal Gold Method – Strip

Maccura Biotechnology Co. Ltd. Chengdu, People’s Republic of  China

EIM4103080

520192

RTK Antibody

Serum

54

Translab (M) Sdn. Bhd.

Maccura SARS-CoV-2 IgM/IgG Antibody Assay Kit  by Colloidal Gold Method – Cassette

Maccura Biotechnology Co. Ltd. Chengdu, People’s Republic of  China

EIM4101080

EIM4102080

520192

RTK Antibody

Serum

55

HWGB Medical Devices & Supplies Sdn Bhd

OJABIO SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal Gold)

Wenzhou OJA Biotechnology Co.,Ltd, China

N/A

ZKHZ21040901

RTK Neutralizing Antibody

Serum

56

Altica Sdn Bhd

Core tests COVID-19 Neutralizing Ab Test

Core Technology Co., Ltd, China

B293-20

20210111

RTK Neutralizing Antibody

Serum

57

Nano Medic Care sdn Bhd

ACON SARS CoV-2 IgG/IgM Rapid Test Cassette (Serum/ Plasma/Whole Blood)

ACON Biotech (Hangzhou) Co., Ltd

[L031-11711]

COV0100002R

RTK Antibody

Serum

58

Interscience Sdn Bhd

StrongStep COVID-19 IgM/IgG Combo Rapid Test Device

Nanjing Liming Bio-Products Co. Ltd., Nanjing, Jiangsu, China

502090

502090

RTK Antibody

Serum

59

Biomarketing Services (M) Sdn Bhd

MAGLUMI SARS-CoV-2 S-RBD IgG (CLIA)

Shenzhen New Industries Biomedical Engineering Co., Ltd, China.

130219017M: 100 tests
130619017M: 50 test

27021030501

Antibody Assay

Serum

60

Translab (M) Sdn Bhd

Zybio 2019-nCoV Neutralizing Antibody Assay (Colloidal Gold)

Zybio Inc., China

2100101

310201

RTK Neutralizing Antibody

Serum

61

Medic Sc Sdn Bhd

AESKULISA® SARS-CoV-2 S1 IgG

AESKU.DIAGNOSTICS GmbH & Co. KG, Germany

6126 : IgG

20480

Antibody Assay

Serum

62

Biomarketing Services (M) Sdn Bhd

cPass™ SARS-CoV-2 Neutralizing Antibody Detection Kit

Genscript Biotech (Singapore) Pte. Ltd. Singapore.

REF: L00847-B (96 tests)
REF: L00847-5B (480 tests)

A210202

Antibody Assay- Neutralizing Antibody

Serum

63

Chemopharm Sdn Bhd

Mindray SARS-CoV-2 Neutralizing Antibodies (CLIA)

Shenzhen Mindray io-Medical Electronics Co., Ltd, China

105-020771-00,
105-020772-00,
105-020777-00,
105-020778-00

2021010100

Neutralizing Antibody Assay

Serum

64

Lab IVF (M) Sdn Bhd

Leccurate SARS-CoV-2 Antibody Test (Colloidal Gold Immunochromatography)

Beijing lepu Medical Technology Co., Ltd., China

N/A

21CG2501X

RTK Antibody

Serum

65

Abbott Laboratories (M) Sdn Bhd

ARCHITECT SARS-CoV-2 IgG II Quant

Abbott Ireland, Ireland

6S60-22
6S60-32
6S60-02
6S60-12

27093FN00

Antibody Assay

Serum

66

Chemopharm Sdn Bhd

Mindray SARS-CoV-2 Total Antibodies (CLIA)

Shenzhen Mindray Bio-Medical Electronics Co., Ltd, China

105-020775-00
105-020776-00
105-020781-00
105-020782-00

2021010400

Antibody Assay

Serum

67

Chemopharm Sdn Bhd

Mindray SARS-CoV-2 S-RBD IgG (CLIA)

Shenzhen Mindray Bio-Medical Electronics Co., Ltd, China

105-020773-00
105-020774-00
105-020779-00
105-020780-00

2021010100

Antibody Assay

Serum

68

DW Labs Sdn Bhd

SARS-CoV-2 Neutralizing Antibody Test Kit (LFIA)

Jiangsu Medomics Medical Technology Co., Ltd

1030-01

20210204

Neutralizing Antibody Assay

Serum

69

EB Holding Sdn Bhd

SGT SARS-CoV-2 In Vitro Neutralizing Antibody Test (IvnAT)

Sugentech, Inc, Korea.

CONE001E

CONE21901

Neutralizing Antibody

Serum

70

Daiichi Biotech Services Sdn Bhd

UNICELL-2019-nCoV Nab (Neutralizing Antibody)

Shenzhen YHLO Biotech Co., Ltd., Shenzhen, China.

F86243

20210303

Neutralizing Antibody

Serum

71

Abbott Laboratories (M) Sdn Bhd

Alinity i SARS-CoV-2 IgG II Quant

Abbott Ireland, Diagnostic Division, Finiskin Business Park, Sligo Ireland.

06S6122 [100 tests/kit] & 06S6132 [500 tests/kit]

27525FN00

Antibody Assay

Serum

72

Tri-G Technologies Sdn Bhd

Bioscience Novel Coronavirus (2019-nCoV) Neutralizing Antibody Rapid Test

Bioscience (Tianjin) Diagnostic technology Co., Ltd, China.

210222CG

20210206

Neutralizing Antibody

Serum

73

Tri-G Technologies Sdn Bhd

RightSign SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette

Hangzhou Biotest Biotech Co., Ltd, China.

ISNB-C41

SNB2106006-S

Neutralizing Antibody

Serum

74

Translab (M) Sdn Bhd

Maccura SARS-CoV-2 Neutralizing Antibody Kit (CLIA)

Maccura Biotechnology Co., Ltd.

EIM4409042: 25 Tests
EIM4410042: 50 Tests
EIM4411042: 100 Tests
EIM4412042: 200 Tests
EIM4413042: 2×25 Tests
EIM4414042: 2×50 Tests
EIM4415042: 2×100 Tests
EIM4416042: 2×200 Tests

421011

Neutralizing Antibody

Serum

75

Medical Innovation Ventures Sdn Bhd

Finecare™ 2019-nCoV RBD Antibody Test

Guangzhou Wondfo Biotech Co. Ltd., China

W290

W-290P0007/08

RTK Antibody

Serum

76

Neoscience Sdn Bhd

STANDARD Q COVID-19 IgM/IgG Plus Test

SD Biosensor, Inc

Reference No.:Q-NCOV-02C
Catalogue No.: 09COV70DM

QCO7021006A

RTK Antibody

Serum

77

Simson Trading Sdn Bhd

LYHER COVID-19 Neutralizing Antibody Test Kit

Hangzhou Laihe Biotech Co., Ltd., China.

303057

2107061

Neutralizing Antibody

Serum

78

Medinics (M) Sdn Bhd

Beright™ SARS-CoV-2 S-RBD IgG Antibody Rapid Test

Hangzhou AllTest Biotech Co., Ltd Zheijang P.R China.

ICSG-402

20210507

RTK Antibody

Serum

79

Premier Diagnostics Sdn Bhd.

Restalyst COVID19-REAAD™ Anti-SARS-CoV-2 IgG ELISA

Restalyst Pte Ltd Singapore

N/A

SL25

Antibody Assay

Serum

80

Teda Wellness Solutions Sdn Bhd

LYHER COVID-19 Neutralizing Antibody

Hangzhou Laihe Biotech Co., Ltd, China

303057

2107061

Neutralizing Antibody

Serum

81

Beckman Coulter Malaysia Sdn Bhd

ACCESS SARS-CoV-2 IgG II
ACCESS SARS-CoV-2 IgG II CALIBRATOR
ACCESS SARS-CoV-2 IgG II QC

Beckman Coulter, Inc., 250 S. Kraemer Blvd., Brea, CA 92821 U.S.A.

C69057

124558

Antibody Assay

Serum

82

Premier Diagnostics Sdn Bhd

Wantai SARS-CoV-2 NAb ELISA

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.

WS-1596

NCOVNAI20210401

Neutralizing Antibody

Serum

83

AcuTest System (M) Sdn Bhd

UNSCIENCE Anti-SARS-CoV-2 Neutralization Antibody Test Kit (Immunofluorescence Assay)

Wuhan UNscience Biotechnology Co., Ltd., Wuhan, Hubei, China.

CP04006-25

20210531

Neutralizing Antibody

Serum

84

Biomarketing Services (M) Sdn Bhd

MAGLUMI SARS-CoV-2 Neutralizing Antibody (CLIA)

Shenzen New Industries Biomedical Engineering Co., Ltd.

130219027M:100 tests/kit

130619027M:050 tests/kit

300210221

Neutralizing Antibody

Serum

85

Dedikasi Semangat Sdn Bhd

BioGerm Diagnostic Kit for 2019-nCoV IgM/IgG Antibody (Colloidal Gold)

Shanghai BioGerm Medical Technology Co., Ltd China.

Not available

20210313A

RTK Antibody

Serum

86

Chemopharm Sdn Bhd

SARS-CoV-2 NeutraLISA

EUROIMMUN Medizinische Labordiagnostika AG , Germany.

EI 2606-9601-4G

E210623AO

Neutralizing Antibody

Serum

87

Pantasniaga Sdn Bhd

Wondfo 2019-nCoV RBD Antibody Rapid Test

Guangzhou Wondfo Biotech Co., Ltd., P.R. China

W632

W63210422YZ

RTK Antibody

Serum

88

JKS Biomedical Sdn. Bhd.

DNK 2019-nCoV IgG/IgM Rapid Test

Dynamiker Biotechnology (Tianjin) Co., Ltd.

DNK-1419-1

210401-HW

RTK Antibody

Serum

89

Conan Medical Technology Berhad

SARS-CoV-2 Neutralizing Antibodies Test Rapid Test Kit System

Xiamen Wiz Biotech Co., Ltd. China

53232104; WIZ-A10

2021042506

Neutralizing Antibody

Serum

90

Daiichi Biotech Services Sdn Bhd

GLINE-2019-nCoV NAb (Neutralization Antibody)

Shenzhen YHLO Biotech Co., Ltd.

G86250

20210000602

Neutralizing Antibody

Serum

91

Chemopharm Sdn Bhd

Anti-SARS-CoV-2 QuantiVac ELISA (IgG)

EUROIMMUN Medizinische Labordiagnostika AG

EI 2606-9601-10 G

E210706BU

Antibody Assay

Serum

92

Top Biotech Sdn Bhd

TOP RAPID COVID-19 Rapid Antibody IgG/IgM Test Kit

Top Biotech Sdn Bhd, Malaysia

Premium Model (with accessory) & Base Model (without accessory)

TBCV03704103S

RTK Antibody

Serum

93

VQM Marketing Sdn Bhd

AllTest SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Whole Blood/Serum/Plasma)

Hangzhou AllTest Biotech Co., Ltd Zhejiang, P.R. China.

ICSG-402

ATCS621070011

RTK Antibody

Serum

94

Translab (M) Sdn Bhd

NADAL® COVID-19 S1-Nab Test (Test Casette)

Nal Von Minden GmbH

243301N-20

SNB2 101011-SG01

Neutralizing Antibody

Serum

95

Nano Medic Care Sdn. Bhd.

Accufast COVID-19 Neutralizing Ab Test

Bao Ruiyuan Biotech (Beijing) Co., Ltd. China

BR30-21

20210719NEU

Neutralizing Antibody

Serum

Updated: 10 November 2021 

Print

  Medical Device Authority (MDA),
Ministry of Health Malaysia,
Level 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
  mdb@mda.gov.my

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