SELF-TEST COVID-19 TEST KIT FOR CONDITIONAL APPROVAL (APPROVED)

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SELF-TEST COVID-19 TEST KIT FOR CONDITIONAL APPROVAL (APPROVED)

 

List of RTK ANTIGEN (Self-Test) 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 is Conditional Approval (please note: list is updated on a routine basis).

Notes:
*Sample type is based on testing facility evaluation report.

 

NO

COMPANY NAME

PRODUCT NAME

MANUFACTURER

IDENTIFIER

LOT NUMBER

1

Reszon Diagnostic International Sdn Bhd

Salixium-COVID-19 Rapid Antigen Rapid Test (Saliva/ Nasal Swab Samples)

Sample type: Saliva and nasal swab samples (Mix Samples)

Reszon Diagnostics International Sdn Bhd. selangor, Malaysia

SLXHB1-0621001

SLXAGl-2105026

2

Citymedic Sdn Bhd

Gmate® COVID-19 Ag Saliva for Home Use

Sample type: Saliva

Philosys Co., Ltd, Republic of Korea

AG-020

CSIOUFAO

3

Medinics (M) Sdn Bhd

BERIGHT-COVID-19 Antigen Rapid Test Device (Oral Fluid)

Sample type: Saliva

 

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

ICOV-802H

ATCOV21060076

4 Neopharma Biotech Asia Sdn Bhd

JusChek COVID-19 Antigen Rapid Test (Oral Fluid)

Sample type: SalivaSample type: Saliva

Hangzhou AllTest Biotech Co., Ltd Zheijang, P.R. China. ICOV-802H ATCOV21060078
5

Global Science Sdn Bhd

ALLTest COVID-19 Antigen Rapid Test (Oral Fluid)

Sample type: Saliva

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

ICOV-802H RATCOV21060077
6 Jingga Anggun Sdn Bhd

Longsee 2019-nCoV Ag & Influenza A/B Rapid Co-Detection Kit (Immunochromatography) Home based Use

Sample type: Saliva

Guangdong Longsee Biomedical Co. Ltd.,Guangzhou,P.R. China LS-C-T-005 CT005210531
7 Hexamine Sdn Bhd

Sichuan Xincheng SARS-CoV-2 Antigen Assay

Sample type: Nasal swab

Sichuan Xincheng Biological Co. Ltd., P.R. China. T4001W 521042
8 Translab (M) Sdn Bhd

Flowflex™ SARS-CoV-2 Antigen Rapid Test (Self-testing)

Sample type: Nasal swab

ACON Biotech (Hangzhou) Co., Ltd., P.R.China L031-118M5 COV1070026
9 Neoscience Sdn Bhd

STANDARD™ Q COVID-19 Ag Saliva Home Test

Sample type: Saliva

SD Biosensor, Inc. Republic of Korea

Ref No: Q-NCOV-02G Cat. No: 09COV131

52D2791AC
10 Medical Innovation Ventures Sdn Bhd

ProDetect™ COVID-19 Antigen Rapid Self-Test (Saliva)

Sample type: Saliva

Medical Innovation Ventures Sdn Bhd, Penang, Malaysia PR-CVDCAgS PR-CVDCAgS21JUL09
11 Dewina Consult Sdn Bhd

NEWGENE Bioengineering COVID-19 Antigen Detection Kit

Sample type: Saliva, Nasal Swab

New Gene (Hangzhou) Bioengineering Co., Ltd. P.R. China COVID-19-NG08 20210501-01
12 Tree Med Sdn Bhd

Lituo COVID-19 Antigen Detection Kit (Colloidal Gold) Self Test Kit

Sample type: Saliva

Zhuhai Lituo Biotechnology Co., Ltd. P. R. China LCV051 20210307
13 Pahang Pharmacy Sdn Bhd

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

Sample type: Saliva

Ningbo Lvtang Biotechnology Co. Ltd., Zhejiang P.R, China. JQ-nCovAg-S NI21G13BJQ
14 Malaysian Diagnostics Corporation Sdn Bhd

Humasis COVID-19 Ag Home Test (Self-Test)

Sample type: Nasal swab

Humasis Co. Ltd., Republic of Korea.

ACOVAGS-7025 COVGCF1015
15 Teda Wellness Solutions Sdn Bhd

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

Sample type: Nasal swab

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

30306 2105032
16 N.A.Z. Medical Supplies Sdn Bhd

ALLTEST COVID-19 Antigen Rapid Test

(Oral Fluid)

Sample type: Saliva

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

ICOV-802H ATCOV21070003
17

Medinics (M) Sdn Bhd

Beright™ SARS-CoV-2 Antigen Rapid Test (Nasal Swab) For Self-testing

Sample type: Nasal swab

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

INCP-502H ATNCP21070001
18 Roche Diagnostics (M) Sdn Bhd

Roche SARS-CoV-2 Antigen Self-Test Nasal

Sample type: Nasal swab

SD Biosensor, Republic of Korea.

9901-NCOV-06G / 09445323077 5822621T1
19 Onecare Biotech Sdn Bhd

ARISTA™ COVID-19 Antigen Rapid Test

Sample type: Nasal swab

ARISTA Biotech Pte. Ltd., Singapore. ARISTA-AG-L1EN-001 ARISTA-AG-L1MY-001 405-07006-2106018
20 SPD Scientific (M) Sdn Bhd

Whistling™ Test 2019-nCoV Saliva Ag Easy Test

Sample type: Saliva

Guangzhou Decheng Biotechnology Co., Ltd, P.R. China. 0709D6G001 0709D6G002 0709D6G005 0709D6G010 0709D6G020 0709D6G025 70210701
21

Hygeia Instruments (Malaysia) Sdn Bhd

Newgene Bioengineering COVID-19 Antigen Detection Kit (For Home Self-Use)

Sample type: Saliva

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

COVID-19-NG08

20210721-01
22

Universal Therapeutics Sdn Bhd

TIB SARS CoV-2 Antigen Rapid Test Kit Saliva

Sample type: Saliva

Triplex International Biosciences (China) Co., Ltd

COV-3S

72101

23 Malaysian Diagnostics Corporation Sdn. Bhd.

V-check 2019-nCoV Ag Saliva Rapid Test Card (Immunochromatography)

Sample type: Saliva

Guangdzhou Decheng Biotechnology Co., Ltd., P.R. China. 0699C8X001
0699C8X005
0699C8X020
52821022C
24 Interscience Sdn Bhd

StrongStep® SARS-CoV-2 Antigen Rapid Test (Self-Test)

Sample type: Nasal swab

Nanjing Liming Bio-Products Co. Ltd., P.R. China. 500200 2108001
25 IMP Enterprise Sdn Bhd

Merlin SARS-CoV-2 Antigen Rapid Test Cassette

Sample type: Nasal swab

Merlin Biomedical (Xiamen) Co., Ltd., P.R.China.

CP01750011
CP01800011
CP01760011

CG00121709
26

IMP Enterprise Sdn Bhd

Merlin SARS-CoV-2 Antigen Rapid Test Cassette

Sample type: Saliva

Merlin Biomedical (Xiamen) Co., Ltd., P.R.China.

CP02140011 CP02150011 CG00221703
27

Onecare Biotech Sdn Bhd

LEPU SARS-CoV-2 Antigen Rapid Test

Sample type: Nasal swab

Beijing Lepu Medical Technology Co., Ltd., P.R. China CG3601 (1-piece pack)
CG3605 (5-piece pack)
CG3610 (10-piece pack)
CG3625 (25-piece pack)
CG3650 (50-piece pack)

21CG3604F

28

NeoScience Sdn Bhd

STANDARD™ Q COVID-19 Ag Home Test

Sample type: Nasal swab

SD Biosensor Inc., Republic of Korea Ref No: Q-NCOV-03G
Cat No:
09COV130 (1T) 09COV130H (2T)
09COV130J (5T)
09COV130D(25T)
58028L1T1
29 ExcelMed Sdn Bhd

SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method) Home Use Self Test Kit

Sample type: Saliva

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

WKI0032

RI21H17BMY

30 City Medic Sdn Bhd

WONDFO 2019-nCoV Antigen Test (Lateral Flow Method) Self Test Saliva

Sample type: Saliva

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

W633P0023,

W633P0024

W63310818YZ

31

Malaysian Diagnostics Corporation Sdn. Bhd.

 Lituo COVID-19  Antigen Detection Kit(Colloidal Gold)

Sample type: Saliva

Zhuhai Lituo Biotechnology, P.R.China

LCV05

20210402

32 Bles Medic Sdn Bhd

Tigsun COVID-19 Saliva Antigen Rapid Test

Sample type: Saliva

Beijing Tigsun Diagnostics Co. Ltd., P.R. China TG-1417

 

14172106

 

33 Universal Therapeutics Sdn Bhd

NEWGENE COVID-19 Antigen Detection Kit

Sample type: Nasal swab, Saliva

New Gene (Hangzhou) Bioengineering Co. Ltd., P.R. China. NG-08 2021082001
34 PMAN Healthcare Specialist Sdn Bhd

Ninonasal® Self-Test

Sample type: Nasal swab

NG Biotech Laboratories, France NGB-COV-S23-302 210305-01-E
35 Arterial Global Sdn. Bhd

SARS-CoV-2 Antigen Rapid Test Cassette (Merlin)

Sample type: Nasal swab

Merlin Biomedical (Xiamen) Co., Ltd., P.R.China. REF CP01750011
(1 test/kit)
REF CP01760011
(20 tests/kit);
REF CP01770011
(50 tests/kit)
REF CP01800011
(1 test/kit);
REF CP01810011
(20 tests/kit
REF CP01820011
(50 tests/kit)
CG00121508
36

Gideons (Malaysia) Sdn Bhd

Novel Coronavirus (2019-nCoV) Antigen Testing Kit (Colloidal Gold)

Sample type: Saliva

Nanjing Norman Biological Technology Co. Ltd., P.R , China 1/25

S2052621

37

XinnerG Sdn Bhd 

Alltest SARS-CoV-2 Antigen Rapid Test (Nasal swab) for Self-Testing

Sample type: Nasal swab

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

INCP-502H ATNCP21070012
38 Damanyu Healthcare Sdn Bhd

Zosbio 2019-nCoV Ag Rapid Test (Immunochromatography)

Sample type: Nasal swab, Saliva

Zhongxiu Science and Technology Co. Ltd., P.R. China

056-B-PD-2

20210701
39 Medical Innovation Ventures Sdn.Bhd

Sejoy SARS-CoV-2 Antigen Rapid Test Cassette

Sample type: Saliva

Hangzhou Sejoy Electronics & Instruments Co. Ltd., P.R. China

COVG-602ST

COVG210806
40 Medical Innovation Ventures Sdn.Bhd

Wondfo 2019 nCoV Antigen Test (Lateral Flow Method)

Sample type: Nasal swab

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

REF W634P0024,

1 test/kit

REF W634P0028,

2 test/kit

REF W634P0025,

5 test/ kit

W63410813YZ

41 Vquest Sdn Bhd

TestNGo COVID-19 Rapid Antigen Saliva Test

SARS-CoV-2 Antigen Test Kit (Self-Test)

Sample type: Saliva

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

SC0238

(1 test per pack)

SC0239

(10 test per pack)

SC0225

(20 test per pack)
21082106
 42  Malaysian Diagnostics Corporation Sdn. Bhd.

CAMTECH COVID-9 Antigen Rapid Self-Test Kit

Sample type: Nasal swab
Camtech Biomedical Pte Ltd Singapore   RTCSV 21070110KS
43 Premier Diagnostics Sdn Bhd

Ecotest COVID-19 Antigen Nasal Test Kit

Sample type: Nasal swab
Assure Tech. (Hangzhou) Co., Ltd. P.R.China. COV-S35002 SR2021080003
44 Naturmax Sdn Bhd

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

Sample type: Saliva
Xiamen Hopegen Medical Technology Co. td., P.R China

COVID-19 Antigen Rapid Test Kit (Colloidal Gold) CVD-RTK-SV

220210702

45 Jingga Anggun Sdn Bhd

Empro Biomed COVID-19 Ag Nasal Self-Test

Sample type: Nasal swab
Jingga Anggun Sdn. Bhd, Malaysia STK-419 EBN 20210926
46 Conan Medical Technology Berhad

Wiz Biotech SARS-CoV-2 Antigen Rapid Test

Sample type: Nasal swab

Xiamen Wiz Biotec Co. Ltd., P.R.China

51432801 2021091704
47 Premier Diagnostics Sdn Bhd

Ecotest Covid-19 Antigen Rapid Test Device (Saliva)

Sample type: Saliva

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

COV-S23003 I2109080
48 K-One MediTech Sdn Bhd

Labnovation SARS-CoV-2 Antigen Saliva Rapid Test Kit

Sample type: Saliva
Labnovation Technologies Inc. P.R China LX-401601 20210929
49 CTK BIOTECH SDN. BHD.

OnSite® COVID-19 Ag Self-Test

Sample type: Nasal swab

CTK Biotech Inc. USA

R0182CST RD1930Da
50 Malaysian Diagnostics Corporation Sdn Bhd

NEWGENE COVID-19 Antigen Detection Kit

Sample type: Nasal swab & Saliva

New Gene (Hangzhou) Bioengineering Co., Ltd. P.R. China COVID-19-NG08 20210801-01
51  Medinics (M) Sdn Bhd

BERIGHT SARS-CoV-2 (COVID-19) Antigen Rapid Test Oral Fluid (Saliva)

Sample type: Saliva
Hangzhou AllTest Biotech Co.Ltd. P.R.China ICOV-803H ATCOV21080253
52 PETROJESS TRADING SDN BHD

ARISTA™ COVID-19 Antigen Rapid Test

Sample type: Nasal swab & Saliva
ARISTA Biotech Pte. Ltd., Singapore

ARISTA-AG-L1EN-001: ARISTA™ COVID-19 Antigen Rapid Test (Self Use) (1 test in single pack)

ARISTA-AG-L1EN-005: ARISTA™ COVID-19 Antigen Rapid Test (Self Use) (5 tests in aggregate pack)

ARISTA-AG-L1EN-010: ARISTA™ COVID-19 Antigen Rapid Test (Self Use) (10 tests in aggregate pack)

ARISTA-AG-L1EN-020: ARISTA™ COVID-19 Antigen Rapid Test (Self Use) (20 tests in aggregate pack)

 ARISTA-AG-L1EN-200: ARISTA™ COVID-19 Antigen Rapid Test (Self Use) (200 tests bulk pack

405-07006-2106018
53 ExcelMed Sdn Bhd

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

Sample type: Nasal swab
Xiamen Jiqing Biomedical Technology Co., Ltd. P.R.China WKI0028 RI21120BMY
54 Convemed Sdn Bhd

VivaDiag SARS-CoV-2 Ag Rapid Test

Sample type: Nasal swab
VivaCheck Biotech (Hangzhou) Co., Ltd. P.R. China VCD05-01-011 SE2103063
55 EB Holdings Sdn Bhd.

SGTi-flex COVID-19 Antigen

Sample type: Nasal swab

Sugentech INC Korea CATGT001E0
CATGT002E0
CATGT005E0
CAGS21001
56 Solid Intellectual Sdn Bhd

NEWGENE COVID-19 Antigen Detection Kit

Sample type: Nasal swab & Saliva

New Gene (Hangzhou) Bioengineering Co., Ltd. P.R. China NG-08 2021082001
57 VQM Marketing Sdn Bhd

ALLTEST COVID-19 Antigen Rapid Test (Oral Fluid) For Self Testing

Sample type: Saliva

Hangzhou AllTest Biotech Co., Ltd. P.R.China. ICOV-802H ATCOV2080091
58 ScienceVision Sdn Bhd

RapidFor™ SARS-CoV-2 Saliva Antigen Test Kit (self-testing)

Sample type: Saliva

Vitrosens Biyoteknoloji Ltd. Sti ,Istanbul Turkey VSCD05 S0521100201
59 B.P. Lab Sdn. Bhd.

Singclean COVID-19 Antigen Test Kit (Colloidal Gold)

Sample type: Saliva

Hangzhou Singclean Medical Products Co., Ltd.P.R.China 6936020115018 59210917A1A
60 Epic Science Sdn. Bhd.

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

Sample type: Saliva
Shenzhen Dymind Biotechnology Co., Ltd.P.R.China R0035
R0037
R0039
20220824
61 Axial Health Sdn. Bhd.

Axial Health COVID-19 Saliva Antigen Rapid Test (Colloid Gold Immunochromatography)

Sample type: Saliva
WFR Medical Supplies SDN BHD,Penang, Malaysia AX-V200 2021061504
62 Axial Health Sdn. Bhd.

Axial Health COVID-19 Salivary Antigen Rapid Test (Colloid Gold Immunochromatography)

Sample type: Saliva
WFR Medical Supplies SDN BHD,Penang, Malaysia AX-V100 2021061504
63 Medi Diastika Sdn Bhd

CAS-ENVISION SARS-CoV-2 Antigen Rapid Detection (Self-Test)

Sample type: Nasal swab & Saliva
CAS-Envision Medical Technology  Co., Ltd. P.R.China CG201A W202105001-STY-1
64 Aureumaex Medicare Marketing (M) Sdn Bhd

One Step Test for SARS-CoV-2 Antigen (Colloidal Gold)

Sample type: Nasal swab
Getein Biotech Inc. P.R.China CG20615
CG206152
CG206153
CG206155
CG206156
CG206157
CG206158
CG206159
CG2061510
CG2061512
CG2061515
CG2061520
CG2061525
PSC213020W
 65  Premier Diagnostics Sdn Bhd

Ecotest COVID-19 Antigen Rapid Test Device (Nasal Swab)

Sample type: Nasal swab

Assure Tech. (Hangzhou) Co., Ltd.P.R.China  CoV-s23004H  SR2021080163 
66 Premier Diagnostics Sdn Bhd

Szybio COVID-19 Antigen Rapid Test Kit (Saliva)

Sample type: Saliva

Wuhan Life Origin Biotech Joint Stock Co., Ltd. P.R.China SF36001 C2107023301
67 MEDICAL INNOVATION VENTURES SDN.BHD

ProDetect™ COVID-19 Antigen Rapid Self-Test

Sample type: Nasal swab
Medical Innovation Ventures Sdn. Bhd. Penang,Malaysia

PR-CVDCAgNS

PR-CVDCAgN1S

PR-CVDCAgN5S

PR-CVDCAgN20S
PRCVDAgN121AUG04
68 Epic Science Sdn. Bhd.

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

Sample type: Nasal swab
Shenzhen Dymind Biotechnology Co., Ltd.P.R.China

R0029

R0030

R0034
2021082501
69 ALLIANCE INTEGRITY TRADING SDN. BHD

Clungene® COVID-19 Antigen Rapid Test

Sample type: Nasal swab
Hangzhou Clongene Biotech Co., Ltd.P.R.China ISCOVu002-700993 S202109023
70 Convemed Sdn Bhd

VivaDiagTM SARS-CoV-2 Ag Saliva Rapid Test

Sample type: Saliva
VivaCheck Biotech (Hangzhou) Co., Ltd.P.R.China VCD17-01-012 SE2103162
71 GEOMICO SDN BHD

BHM® COVID-19 Antigen Rapid Test

Sample type: Nasal swab
Birmingham Biotech Ltd. England

BBIO001

G2108003
72 Global Glades Medic Sdn. Bhd.

One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) (Saliva) Test Kit

Sample type: Saliva
Getein Biotech Inc. P.R China CG20616
CG206162
CG206163
CG206165
CG206166
CG206167
CG206168
CG206169
CG2061610
CG2061612
CG2061615
CG2061620
CG2061625
PSC213031W
73 Teda Wellness Solutions Sdn Bhd

Raycus COVID-19 Ag Rapid Test Kit - Saliva self-testing

Sample type: Saliva
Anhui Raycus Biological Technology Co., Ltd.P.R.China RC2021ST C20211001
74 Jingga Anggun Sdn Bhd

LONGSEE 2019-nCoV Ag Rapid Detection Kit (Immuno-Chromatography)

Sample type: Saliva
Guangdong Longsee Biomedical Co., Ltd. P.R.China LS-C-T-008 CT008210705
75 Rocky Scientific Instrumentation

KISSH SARS-CoV-2 Antigen Test Kit (GICA)-Saliva

Sample type: Saliva

Shenzen Kisshealth Biotechnology Co., Ltd.P.R.China

K602-1S
K602-3S
K602-5S
20210825
76 SPD Scientific (M) Sdn Bhd

V-Chek 2019-nCoV Antigen Rapid Test Kit (Immunochromatography)

Sample type: Nasal swab
Guangzhou Decheng Biotechnology Co., LTD. P.R. China 0555C2X001 68210701
77 XinnerG Sdn Bhd

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

Sample type: Saliva
Genrui Biotech Inc. P.R. China

52104098 (1 test kit)

52112087 (5 test kit)

52026095 (25 test kit)
20210618
78 Rapport Medilines Sdn. Bhd

One-step Test for SARS-CoV-2 Antigen (Colloidal Gold) (Saliva)

Sample type: Saliva
Getein Biotech Inc. P.R.China CG20616
CG206162
CG206163
CG206165
CG206166
CG206167
CG206168
CG206169
CG2061610
CG2061612
CG2061615
CG2061620
CG2061625
PSC213029W
79 Dyna Source Sdn Bhd

BioDetect Rapid SARS-CoV-2 Antigen Test Card (Self-test)

Sample type: Nasal swab
BioDetect (Xiamen) Biotechnology Co., Ltd. P.R.China GMT102 T220050901
80 SPD Scientific (M) Sdn. Bhd.

Green Spring SARS-CoV-2 Antigen Rapid Test Kit(Colloidal Gold)

Sample type: Nasal swab

Shenzhen Lvshiyuan Biotechnology Co., Ltd.P.R.China GF102B1S 20210401
81 Watercress Communications Sdn Bhd

eDiagnosis COVID-19 (SARS-CoV-2) Antigen Test Kit

Sample type: Nasal swab
Wuhan EasyDiagnosis Biomedicine Co., Ltd. P.R.China W-AgH-20 (20 test kits)
W-AgH-05S (5 test kits)
W-AgH-01S (1 test kits)
21070102
82 K-One MediTech Sdn Bhd

Medkaire SARS-CoV-2 Antigen Kit (Saliva) Self-Testing

Sample type: Saliva
Goldsite Diagnostic Inc.P.R.China CG123101 20210906
83 Starvillion Sdn Bhd

GICA - TESTSEALABS® COVID-19 Antigen Test Cassette

Sample type: Saliva
Hangzhou Testea Biotechnology Co., Ltd.P.R.China TCS 1903 HJJ040102

 

Updated: 24 November 2021

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