CONDITIONAL APPROVAL LIST OF COVID-19 TEST KIT (FOR SELF-TEST)
The list of Self-Test Covid-19 Test Kit that is approved for Conditional Approval 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 evidence.
- the evaluation test results from testing facilities are according to the committee evaluation criteria set by Clinical expert panels.
- Supporting Documents for COVID-19 IVD Test Kits Conditional Approval.
The use of COVID-19 self- test kit shall be limited for screening purpose only and all test results need further confirmation using RT-PCR.
Below is the list of all tests that have been selected to date and the status of Conditional Approval is still VALID (please note: list is updated on a routine basis).
For registered Self-Test Covid-19 Test Kit, please refer to Medical Device Authority Register (MDAR)
|
NO |
COMPANY NAME |
BRAND |
PRODUCT NAME |
MANUFACTURER |
IDENTIFIER |
LOT NUMBER |
ISSUED DATE |
VALID UNTIL |
|
1 |
RZAC Business Sdn. Bhd. |
HIGHTOP |
HIGHTOP SARS-Cov2 Antigen Rapid Test Sample Type: Nasal swab |
Hightop Biotech Co Ltd. P.R.China |
H100G-23S |
COV-1210416 |
3/3/2022 |
3/3/2023 |
|
2 |
UC Bioscience Sdn Bhd |
Medomics |
Medomics SARS-CoV-2 Antigen Test Kit (LFIA) Sample Type: Nasal swab |
Jiangsu Medomics Medical Technology Co., Ltd.P.R.China |
1031-14-01 1031-34-01 1031-54-01 |
20210729 |
11/3/2022 |
11/3/2023 |
|
3 |
STARVILION SDN BHD |
Gruenbanka |
SARS-CoV-2 Antigen Detection Kit (Saliva) Sample type: Saliva |
Ningbo Lvtang Biotechnology Co., Ltd.P.R. China |
JQ-nCovAg-S |
NI211003AMY |
14/3/2022 |
14/3/2023 |
|
4 |
Axial Health Sdn Bhd |
Axial Health |
Axial Health COVID-19 Saliva Antigen Rapid Test Kit Sample type: Saliva |
Kibaru Manufacturing Sdn Bhd, Kedah Malaysia |
V300 (AX-V300) |
20210819 |
15/3/2022 |
15/3/2023 |
|
5 |
Aliya Suria Sdn Bhd |
NP |
COVID-19 Antigen Rapid Test Cassette (Saliva) Sample type: Saliva |
Jiangsu Diagnostics Biotechnology Co.,Ltd, P.R.China |
CP023-01 |
20210909002 |
28/3/2022 |
28/3/2023 |
|
6 |
TOP BIOTECH SDN. BHD. |
TOP RAPID |
COVID-19 Rapid Saliva Plus Test Kit Sample type: Saliva |
TOP BIOTECH SDN BHD, Selangor, Malaysia. |
RTB/COVSlv/AG/3.0/A RTB/COVSlv/AG/3.0/B |
T BCV04030012101NP |
12/4/2022 |
12/4/2023 |
|
7 |
WFR Medical Supplies Sdn Bhd |
WFR |
COVID-19 SALIVARY ANTIGEN HOME TEST KIT Sample type: Saliva |
WFR Medical Supplies Sdn Bhd Ltd, Penang Malaysia |
WHS-5000 |
5SH2021061504 |
22/4/2022 |
22/4/2023 |
|
8 |
Arterial Global Sdn. Bhd |
Merlin Biomedical (Xiamen) Co., Ltd. |
SARS-CoV-2 Antigen Rapid Test Cassette Sample type: Saliva |
Merlin Biomedical (Xiamen) Co., Ltd.P.R.China |
CP02140011 CP02150011 |
CG00222208 |
22/4/2022 |
22/4/2023 |
|
9 |
CONAN MEDICAL TECHNOLOGY BERHAD |
WizBiotech |
SARS-CoV-2 Antigen Rapid Test (Saliva) Sample type: Saliva |
Xiamen Wiz Biotech Co., Ltd. P. R. China |
51432711 (1 test per kit) |
2022011503 |
27/4/2022 |
27/4/2023 |
|
10 |
NeoScience Sdn Bhd. |
STANDARDTM i-Q |
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) Sample type: Nasal Swab |
Nanjing Vazyme Medical Technology Co., Ltd., P. R. China |
C8611CH C8610CH C8602CH |
V0122011257C |
9/5/2022 |
9/5/2023 |
|
11 |
Bumi Genomics Innovation Sdn Bhd |
Innovita |
Innovita 2019-nCoV Ag Test (Latex Chromatography Assay)- Nasal Swab Sample type: Nasal Swab |
Innovita (Tangshan) Biological Technology Co., Ltd. P.R.China |
YF320C-NS-HU-1T |
20220202 |
10/5/2022 |
10/5/2023 |
|
12 |
Neopharma Biotech Asia Sdn Bhd |
FASPIT™ |
SARS-CoV-2 Antigen Saliva Test (For Self-Testing Use) Brand: FASPIT™ Sample type: Saliva |
Atlas Link Technology Co., Ltd., P. R. China |
C2112 |
20220309 |
10/5/2022 |
10/5/2023 |
|
13 |
Reszon Diagnostics International Sdn. Bhd. |
Reszon |
Reszon COVID-19 Rapid Antigen Test (Saliva) Sample type: Saliva |
Reszon Diagnostic International Sdn. Bhd, Kuala Lumpur Malaysia. |
RCV-RD0201S-01 RCV-RD0201S-10 RCV-RD0201S-25 |
202202003 |
10/5/2022 |
10/5/2023 |
|
14 |
UC Biosciences Sdn Bhd |
CAS-ENVISION |
CAS-ENVISION SARS-CoV-2 Antigen Rapid Detection (Self-Test) Sample type: Nasal Swab and Saliva |
Shenzhen CAS-Envision Medical Technology Co., Ltd., China.P.R.China |
CG201A_STY-1 CG201A_STY-5 |
W202111007-STY-1 |
24/5/2022 |
24/5/2023 |
|
15 |
Smarttech Engineering and Resource Management Sdn Bhd |
NEWGENE |
COVID-19 Antigen Detection Kit Sample type: Nasal swab and saliva |
New Gene (Hangzhou) Bioengineering Co., Ltd.,P.R. China |
COVID-19-NG08 |
20211201-01 |
2/6/2022 |
2/6/2023 |
|
16 |
MEDICAL INNOVATION VENTURES SDN.BHD |
TEPAT |
TEPAT COVID-19 Ag Saliva Lolly Self-Test Sample type: Saliva |
MEDICAL INNOVATION VENTURES SDN.BHD, Malaysia |
TP-CVDAgSLM |
TP-CVDAgSLM521NOV22 |
13/6/2022 |
13/6/2023 |
|
17 |
MEDICAL INNOVATION VENTURES SDN.BHD |
ProDetect® |
ProDetect® COVID-19 Antigen Saliva Rapid Self-Test Sample type: Saliva |
MEDICAL INNOVATION VENTURES SDN.BHD , Malaysia |
PR-CVDAgS |
PCR-CVDAgS22FEB03 |
13/6/2022 |
13/6/2023 |
|
18 |
World Medicare Supplies Sdn Bhd |
SUNWAY |
SUNWAY COVID-19 Antigen Rapid Saliva Test Kit (Colloidal Gold) Sample type: Saliva |
Xiamen Hopegen Medical Technology Co., Ltd.,P.R. China |
SW-2-0201 (1 test/box) SW-2-0205 (5 tests/box) SW-2-0225 (25 tests/box) |
220210702 |
30/6/2022 |
30/6/2023 |
|
19 |
NeoScience Sdn Bhd. |
SD Biosensor, Inc. KOREA |
STANDARD i-Q COVID-19 Ag Home Test Sample type: Nasal swab |
SD Biosensor, Inc C-4&5Floor, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, REPUBLIC OF KOREA |
EQ-NCOV-03G |
57833A1AC |
12/7/2022 |
12/7/2023 |
|
20 |
Laurent Bleu Sdn Bhd, |
Laurent Bleu |
COVID-19 Antigen Rapid Test Kit (Colloidal Gold) Sample type: Saliva |
Aikang Diagnostics Co., Ltd. P.R.China |
1 Test/kit REF:AKBR4027001 |
20210802 |
25/7/2022 |
25/7/2023 |
|
21 |
Porrima (M) Sdn. Bhd |
MODA |
MODA SARS-CoV-2 Antigen Rapid Test Kit (Saliva) Sample type: Saliva |
ChongQing MODA Biotechnology Co., Ltd.,P.R. China |
MCOV-101 (1 test kit) |
20220301 |
20/7/2022 |
20/7/2023 |
|
22 |
PHARMAFORTE (M) SDN BHD |
DIASIA |
COVID-19(SARS-COV-2) ANTIGEN TEST KIT Sample type: Nasal Swab |
DIASIA BIOMEDICAL TECHNOLOGY CO.LTD.P.R.China |
22300001 (2190001) |
20220307 |
22/8/2022 |
22/8/2023 |
|
23 |
Fun N Cheer Sdn Bhd |
Getein Biotech, Inc. |
Getein Biotech GP One Step Test For SARS-CoV-2 Antigen (Colloidal Gold) Sample Type: Nasal swab and saliva |
Getein Biotech, Inc.P.R. China |
CG2061 |
6SC216035W |
10/8/2022 |
10/8/2023 |
|
24 |
Chemopharm Sdn. Bhd. |
Babio |
Babio SARS-CoV-2 Antigen Rapid Detection Kit (Colloidal Gold Method) – Nasal |
Jinan Babio Biotechnology Co., Ltd., P.R. China |
011521, 011522 |
22022511 |
12/8/2022 |
12/8/2023
|
|
Expiring soon |
|
|
Still valid |
Updated: 21st February 2023
