CONDITIONAL APPROVAL LIST OF COVID-19 TEST KIT (FOR SELF-TEST)
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 is Conditional Approval (please note: list is updated on a routine basis).
Notes:
*Sample type is based on testing facility evaluation report.
Conditional Approval status:
|
LIST OF RTK ANTIGEN (SELF-TEST) List Covid-19 self-test registered |
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|
NO |
COMPANY NAME |
BRAND |
PRODUCT NAME |
MANUFACTURER |
IDENTIFIER |
LOT NUMBER |
ISSUED DATE |
VALID UNTIL |
STATUS MEDICAL DEVICE |
|
1 |
Citymedic Sdn Bhd |
Gmate® |
Gmate® COVID-19 Ag Saliva for Home Use Sample type: Saliva |
Philosys Co., Ltd, Republic of Korea |
AG-020 |
CSIOUFAO |
20/06/2022 |
19/06/2027 |
IVDC6173222-95652 |
|
2 |
Global Science Sdn Bhd |
ALLTest |
ALLTest COVID-19 Antigen Rapid Test (Oral Fluid) Sample type: Saliva |
Hangzhou AllTest Biotech Co., Ltd Zheijang, P.R. China. |
ICOV-802H |
ATCOV21060077 |
19/07/2022 |
18/07/2027 |
IVDC4160422-97856 |
|
3 |
Onecare Biotech Sdn Bhd |
LEPU |
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 New Lot Number: 21CG3610F |
18/07/2022 |
17/07/2027 |
IVDC3955422-98043 |
|
4 |
Premier Diagnostics Sdn Bhd |
Ecotest |
Ecotest Covid-19 Antigen Rapid Test Device (Saliva) Sample type: Saliva |
Assure Tech (Hangzhou) Co. Ltd. P.R. China |
COV-S23003 |
I2109080 |
15/06/2022 |
14/06/2027 |
IVDC7156922-94712 |
|
5 |
ALLIANCE INTEGRITY TRADING SDN. BHD |
Clungene® |
Clungene® COVID-19 Antigen Rapid Test Sample type: Nasal swab |
Hangzhou Clongene Biotech Co., Ltd.P.R.China |
ISCOVu002-700993 |
S202109023 |
18/07/2022 |
17/07/2027 |
IVDC5968222-97812 |
|
6 |
Dyna Source Sdn Bhd |
BDT |
Rapid SARS-CoV-2 Antigen Test Card (Saliva) Sample type: Saliva |
BioDetect (Xiamen) Biotechology Co., Ltd.. P.R.China |
GMT104 |
T221081101 |
22/07/2022 |
21/07/2027 |
IVDC6522522-98193 |
|
7 |
Medi Diastika Sdn Bhd |
CAS-ENVISION |
CAS-ENVISION SARS-CoV-2 Antigen Rapid Detection (Self-Test) |
CAS-Envision Medical Technology Co., Ltd. P.R.China |
CG201A |
W202105001-STY-1 |
18/07/2022 |
17/07/2027 |
IVDC2731522-98071 |
|
8 |
Premier Diagnostics Sdn Bhd |
Szybio |
Szybio COVID-19 Antigen Rapid Test Kit (Saliva) |
Wuhan Life Origin Biotech Joint Stock Co., Ltd. P.R.China |
SF36001 |
C2107023301 |
18/07/2022 |
17/07/2027 |
IVDC9975922-97468 |
|
9 |
Smarttech Engineering And Resource Management Sdn. Bhd. |
GENFARM |
SARS-COV-2 ANTIGEN DETECTION KIT (SALIVA) Sample type: Saliva |
NINGBO LVTANG BIOTECHNOLOGY CO., LTD |
COVAG-S |
22011501AGL |
18/07/2022 |
17/07/2027 |
IVDC2171822-97680 |
|
10 |
Reszon Diagnostic International Sdn Bhd |
Salixium |
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 |
02/08/2022 |
01/08/2027 |
IVDC5125422-99355 |
|
11 |
Medinics (M) Sdn Bhd |
BERIGHT |
BERIGHT-COVID-19 Antigen Rapid Test Device (Oral Fluid) Sample type: Saliva |
Hangzhou AllTest Biotech Co., Ltd. Zheijang, P.R. China. |
ICOV-802H |
ATCOV21060076 |
18/08/2022 |
17/08/2027 |
IVDC7668522-101529 |
|
12 |
Neopharma Biotech Asia Sdn Bhd |
JusChek |
JusChek COVID-19 Antigen Rapid Test (Oral Fluid) Sample type: Saliva |
Hangzhou AllTest Biotech Co., Ltd Zheijang, P.R. China. |
ICOV-802H |
ATCOV21060078 |
15/08/2022 |
14/08/2027 |
IVDC9978422-101343 |
|
13 |
Malaysian Diagnostics Corporation Sdn Bhd |
Humasis |
Humasis COVID-19 Ag Home Test (Self-Test) Sample type: Nasal swab |
Humasis Co. Ltd., Republic of Korea. |
ACOVAGS-7025 |
COVGCF1015 |
04/08/2022 |
03/08/2027 |
IVDC9482422-100389 |
|
14 |
Medinics (M) Sdn Bhd |
Beright™ |
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 |
18/08/2022 |
17/08/2027 |
IVDC9233122-101531 |
|
15 |
Universal Therapeutics Sdn Bhd |
NEWGENE |
NEWGENE COVID-19 Antigen Detection Kit Sample type: Nasal swab, Saliva |
New Gene (Hangzhou) Bioengineering Co. Ltd., P.R. China. |
NG-08 |
2021082001 |
22/08/2022 |
21/08/2027 |
IVDC4656122-101627 |
|
16 |
K-One MediTech Sdn Bhd |
Labnovation |
Labnovation SARS-CoV-2 Antigen Saliva Rapid Test Kit Sample type: Saliva |
Labnovation Technologies Inc. P.R China |
LX-401601 |
20210929 |
15/08/2022 |
14/08/2027 |
IVDC8213322-101341 |
|
17 |
Arterial Global Sdn. Bhd |
Merlin |
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 |
16/08/2022 |
15/08/2027 |
IVDC7918922-101321 |
|
18 |
XinnerG Sdn Bhd |
Alltest |
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 |
18/08/2022 |
17/08/2027 |
IVDC4337222-101559 |
|
19 |
B.P. Lab Sdn. Bhd. |
Singclean |
Singclean COVID-19 Antigen Test Kit (Colloidal Gold) Sample type: Saliva |
Hangzhou Singclean Medical Products Co., Ltd.P.R.China |
6936020115018 |
59210917A1A |
05/08/2022 |
04/08/2027 |
IVDC5794122-100441 |
|
20 |
Medi Diastika Sdn Bhd |
CAS-ENVISION |
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 |
18/07/2022 |
17/07/2027 |
IVDC2731522-98071 |
|
21 |
XinnerG Sdn Bhd |
Genrui |
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 |
02/08/2022 |
01/08/2027 |
IVDC7840922-99345 |
|
22 |
Medi Diastika Sdn. Bhd. |
CAS-ENVISION |
CAS-ENVISION SARS-CoV-2 Antigen Rapid Detection Kit Sample type: Saliva |
CAS-Envision Medical Technology Co., Ltd.P.R.CHINA |
CG201A-SS1 |
WH202202002 |
25/08/2022 |
24/08/2027 |
IVDC9512622-102805 |
|
23 |
Medical Innovation Ventures Sdn Bhd |
ProDetect™ |
ProDetect™ COVID-19 Antigen Rapid Self-Test (Saliva) Sample type: Saliva |
Medical Innovation Ventures Sdn Bhd, Penang, Malaysia |
PR-CVDCAgS |
PR-CVDCAgS21JUL09 |
15/08/2022 |
14/08/2027 |
IVDC10583422-100689 |
|
24 |
Malaysian Diagnostics Corporation Sdn Bhd |
NEWGENE |
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 |
15/08/2022 |
14/08/2027 |
IVDC5384922-101425 |
|
25 |
QUANTUM BIOMEDICAL SERVICES SDN. BHD. |
GATEIN BIOTECH INC. |
ONE STEP TEST FOR SARS-COV-2 ANTIGEN (COLLOIDAL GOLD) Sample type: Nasal swab |
Getein Biotech, Inc., Nanjing, P.R.China |
CG2061 CG20615 CG206155 |
PSC213020W |
01/08/2022 |
31/07/2027 |
IVDC8806322-100251 |
|
|
|||||||||
|
Status Conditional approval expired |
|||||||||
|
NO |
COMPANY NAME |
BRAND |
PRODUCT NAME |
MANUFACTURER |
IDENTIFIER |
LOT NUMBER |
ISSUED DATE |
VALID UNTIL |
STATUS MEDICAL DEVICE |
|
1 |
Jingga Anggun Sdn Bhd |
Longsee |
Longsee 2019-nCoV Ag & Influenza A/B Co-detectionKit (Immuno-Chromatography) - Home Based Use LS-C-T-005 Sample type: Saliva |
Guangdong Longsee Biomedical Co. Ltd., Guangzhou, P.R. China |
LS-C-T-005 |
CT005210531 |
28/7/2021 |
28/7/2022 |
NA |
|
2 |
Hexamine Sdn Bhd |
Sichuan Xincheng (Diacegene) |
Sichuan Xincheng (Diacegene) SARS-CoV-2 Antigen Assay Sample type: Nasal swab |
Sichuan Xincheng Biological Co. Ltd., P.R. China. |
T4001W |
521042 |
9/8/2021 |
9/8/2022 |
NA |
|
3 |
Translab (M) Sdn Bhd |
Flowflex™ |
Flowflex™ SARS-CoV-2 Antigen Rapid Test (Self-testing) Sample type: Nasal swab |
ACON Biotech (Hangzhou) Co., Ltd., P.R.China |
L031-118M5 |
COV1070026 |
11/8/2021 |
11/8/2022 |
NA |
|
4 |
Neoscience Sdn Bhd |
STANDARD™ |
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 |
12/8/2021 |
12/8/2022 |
NA |
|
5 |
Dewina Consult Sdn Bhd |
NEWGENE |
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 |
12/8/2021 |
12/8/2022 |
NA |
|
6 |
Tree Med Sdn Bhd |
Lituo |
Lituo COVID-19 Antigen Detection Kit (Colloidal Gold) Self Test Kit Sample type: Saliva |
Zhuhai Lituo Biotechnology Co., Ltd. P. R. China |
LCV051 |
20210307 |
20/8/2021 |
20/8/2022 |
NA |
|
7 |
Pahang Pharmacy Sdn Bhd |
GRUENBANKA |
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 |
20/8/2021 |
20/8/2022 |
NA |
|
8 |
Teda Wellness Solutions Sdn Bhd |
LYHER® |
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 |
2/9/2021 |
2/9/2022 |
NA |
|
9 |
N.A.Z. Medical Supplies Sdn Bhd |
ALLTEST |
ALLTEST COVID-19 Antigen Rapid Test (Oral Fluid) Sample type: Saliva |
Hangzhou Alltest Biotech Co., Ltd. Hangzhou,P.R.China. |
ICOV-802H |
ATCOV21070003 |
3/9/2021 |
3/9/2022 |
NA |
|
10 |
Roche Diagnostics (M) Sdn Bhd |
Roche |
Roche SARS-CoV-2 Antigen Self-Test Nasal Sample type: Nasal swab |
SD Biosensor, Republic of Korea. |
9901-NCOV-06G / 09445323077 |
5822621T1 |
6/9/2021 |
6/9/2022 |
NA |
|
|
|||||||||
|
Status Conditional Approval still valid and will be expired soon |
|||||||||
|
NO |
COMPANY NAME |
BRAND |
PRODUCT NAME |
MANUFACTURER |
IDENTIFIER |
LOT NUMBER |
ISSUED DATE |
VALID UNTIL |
STATUS MEDICAL DEVICE |
|
1 |
Onecare Biotech Sdn Bhd |
ARISTA™ |
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 |
21/09/2021 |
21/09/2022 |
NA |
|
2 |
SPD Scientific (M) Sdn Bhd |
Whistling™ |
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 New Lot No: 070211101 070211102 070211103 070211104 070211105 070211106 070211107 |
24/9/2021 |
24/9/2022 |
NA |
|
3 |
Hygeia Instruments (Malaysia) Sdn Bhd |
Newgene |
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 |
28/9/2021 |
28/9/2022 |
NA |
|
4 |
Universal Therapeutics Sdn Bhd |
TIB |
TIB SARS CoV-2 Antigen Rapid Test Kit Saliva Sample type: Saliva |
Triplex International Biosciences (China) Co., Ltd |
COV-3S |
72101 |
1/10/2021 |
1/10/2022 |
NA |
|
5 |
Malaysian Diagnostics Corporation Sdn. Bhd. |
V-check |
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 New Lot No: 69211102 |
4/10/2021 |
4/10/2022 |
NA |
|
6 |
Interscience Sdn Bhd |
StrongStep® |
StrongStep® SARS-CoV-2 Antigen Rapid Test (Self-Test) Sample type: Nasal swab |
Nanjing Liming Bio-Products Co. Ltd., P.R. China. |
500200 |
2108001 |
5/10/2021 |
5/10/2022 |
NA |
|
7 |
IMP Enterprise Sdn Bhd |
Merlin |
Merlin SARS-CoV-2 Antigen Rapid Test Cassette Sample type: Nasal swab |
Merlin Biomedical (Xiamen) Co., Ltd., P.R.China. |
CP01750011 CP01800011 CP01760011 |
CG00121709 |
7/10/2021 |
7/10/2022 |
NA |
|
8 |
IMP Enterprise Sdn Bhd |
Merlin |
Merlin SARS-CoV-2 Antigen Rapid Test Cassette Sample type: Saliva |
Merlin Biomedical (Xiamen) Co., Ltd., P.R.China. |
CP02140011 CP02150011 |
CG00221703 |
7/10/2021 |
7/10/2022 |
NA |
|
9 |
NeoScience Sdn Bhd |
STANDARD™ |
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 |
8/10/2021 |
8/10/2022 |
NA |
|
10 |
ExcelMed Sdn Bhd |
Wikang |
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 New lot number: NI21L01AMY NI21L02AMY NI21K15AMY |
11/10/2021 |
11/10/2022 |
NA |
|
11 |
City Medic Sdn Bhd |
WONDFO |
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 |
11/10/2021 |
11/10/2022 |
NA |
|
12 |
Malaysian Diagnostics Corporation Sdn. Bhd. |
Lituo |
Lituo COVID-19 Antigen Detection Kit(Colloidal Gold) Sample type: Saliva |
Zhuhai Lituo Biotechnology, P.R.China |
LCV05 |
20210402 |
11/10/2021 |
11/10/2022 |
NA |
|
13 |
Bles Medic Sdn Bhd |
Tigsun |
Tigsun COVID-19 Saliva Antigen Rapid Test Sample type: Saliva |
Beijing Tigsun Diagnostics Co. Ltd., P.R. China. |
TG-1417 |
14172106 |
11/10/2021 |
11/10/2022 |
NA |
|
14 |
PMAN Healthcare Specialist Sdn Bhd |
Ninonasal® |
Ninonasal® Self-Test Sample type: Nasal swab |
NG Biotech Laboratories, France |
NGB-COV-S23-302 |
210305-01-E |
13/10/2021 |
13/10/2022 |
NA |
|
15 |
Gideons (Malaysia) Sdn Bhd |
Norman |
Novel Coronavirus (2019-nCoV) Antigen Testing Kit (Colloidal Gold) Sample type: Saliva |
Nanjing Norman Biological Technology Co. Ltd., P.R , China |
1/25 |
S2052621 |
14/10/2021- |
14/10/2022 |
NA |
|
16 |
Damanyu Healthcare Sdn Bhd |
Zosbio |
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 |
14/10/2021 |
14/10/2022 |
NA |
|
17 |
Medical Innovation Ventures Sdn.Bhd |
Sejoy |
Sejoy SARS-CoV-2 Antigen Rapid Test Cassette Sample type: Saliva |
Hangzhou Sejoy Electronics & Instruments Co. Ltd., P.R. China |
COVG-602ST |
COVG210806 |
15/10/2021 |
15/10/2022 |
NA |
|
18 |
Medical Innovation Ventures Sdn.Bhd |
Wondfo |
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 |
15/10/2021 |
15/10/2022 |
NA |
|
19 |
Vquest Sdn Bhd |
TestNGo |
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 |
15/10/2021 |
15/10/2022 |
NA |
|
20 |
Malaysian Diagnostics Corporation Sdn. Bhd. |
CAMTECH |
CAMTECH COVID-9 Antigen Rapid Self-Test Kit Sample type: Nasal swab |
Camtech Biomedical Pte Ltd Singapore |
RTCSV |
21070110KS |
20/10/2021 |
20/10/2022 |
NA |
|
21 |
Premier Diagnostics Sdn Bhd |
Ecotest |
Ecotest COVID-19 Antigen Nasal Test Kit Sample type: Nasal swab |
Assure Tech. (Hangzhou) Co., Ltd. P.R.China. |
COV-S35002 |
SR2021080003 |
22/10/2021 |
22/10/2022 |
NA |
|
22 |
Naturmax Sdn Bhd |
Hopegene |
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 |
25/10/2021 |
25/10/2022 |
NA |
|
23 |
Jingga Anggun Sdn Bhd |
Empro |
Empro Biomed COVID-19 Ag Nasal Self-Test Sample type: Nasal swab |
Jingga Anggun Sdn. Bhd, Malaysia |
STK-419 |
EBN 20210926 |
25/10/2021 |
25/10/2022 |
NA |
|
24 |
CTK BIOTECH SDN. BHD. |
OnSite® |
OnSite® COVID-19 Ag Self-Test Sample type: Nasal swab |
CTK Biotech Inc. USA |
R0182CST |
RD1930Da New Lot Number: F0126T2A00DB F0210T2A00DB |
26/10/2021 |
26/10/2022 |
NA |
|
25 |
Medinics (M) Sdn Bhd |
BERIGHT |
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 |
28/10/2021 |
28/10/2022 |
NA |
|
26 |
PETROJESS TRADING SDN BHD |
ARISTA™ |
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)
|
405-07006-2106018 |
28/10/2021 |
28/10/2022 |
NA |
|
27 |
ExcelMed Sdn Bhd |
Wikang |
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 New lot number: NI21K18BMY NI21LO3AMY |
28/10/2021 |
28/10/2022 |
NA |
|
29 |
Convemed Sdn Bhd |
VivaDiag |
VivaDiag SARS-CoV-2 Ag Rapid Test Sample type: Nasal swab |
VivaCheck Biotech (Hangzhou) Co., Ltd. P.R. China |
VCD05-01-011 |
SE2103063 |
29/10/2021 |
29/10/2022 |
NA |
|
30 |
EB Holdings Sdn Bhd |
Sugentech |
SGTi-flex COVID-19 Antigen Sample type: Nasal swab |
Sugentech INC Korea |
CAGT001E0 CAGT002E0 CAGT005E0 |
CAGS21001 |
1/11/2021 |
1/11/2022 |
NA |
|
31 |
Solid Intellectual Sdn Bhd |
NEWGENE |
NEWGENE COVID-19 Antigen Detection Kit Sample type: Nasal swab & Saliva |
New Gene (Hangzhou) Bioengineering Co., Ltd. P.R. China |
NG-08 |
2021082001 20211220-01 |
1/11/2021 |
1/11/2022 |
NA |
|
32 |
VQM Marketing Sdn Bhd |
ALLTEST |
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 |
1/11/2021 |
1/11/2022 |
NA |
|
33 |
ScienceVision Sdn Bhd |
RapidFor™ |
RapidFor™ SARS-CoV-2 Saliva Antigen Test Kit (self-testing) Sample type: Saliva |
Vitrosens Biyoteknoloji Ltd. Sti ,Istanbul Turkey |
VSCD05 |
S0521100201 |
2/11/2021 |
2/11/2022 |
NA |
|
34 |
Epic Science Sdn. Bhd. |
Dymind |
Dymind SARS-CoV-2 Antigen Test Kit (Colloidal Gold) Sample type: Saliva |
Shenzhen Dymind Biotechnology Co., Ltd.P.R.China |
R0035 |
20220824 |
9/11/2021 |
9/11/2022 |
NA |
|
35 |
Axial Health Sdn. Bhd. |
Axial Health |
Axial Health COVID-19 Saliva Antigen Rapid Test (Colloid Gold Immunochromatography) Sample type: Saliva |
WFR Medical Supplies SDN BHD,Penang, Malaysia |
AX-V200 |
2021061504 |
10/11/2021 |
10/11/2022 |
NA |
|
36 |
Aureumaex Medicare Marketing (M) Sdn Bhd |
GP |
One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) Sample type: Nasal swab |
Getein Biotech Inc. P.R.China |
CG20615 |
PSC213020W |
10/11/2021 |
10/11/2022 |
NA |
|
37 |
Premier Diagnostics Sdn Bhd |
Ecotest |
Ecotest COVID-19 Antigen Rapid Test Device (Nasal Swab) Sample type: Nasal swab |
Assure Tech. (Hangzhou) Co., Ltd.P.R.China |
CoV-s23004H |
SR2021080163 |
12/11/2021 |
12/11/2022 |
NA |
|
38 |
Premier Diagnostics Sdn Bhd |
Szybio |
Szybio COVID-19 Antigen Rapid Test Kit (Saliva) Sample type: Saliva |
Wuhan Life Origin Biotech Joint Stock Co., Ltd. P.R.China |
SF36001 |
C2107023301 |
12/11/2021 |
12/11/2022 |
NA |
|
39 |
MEDICAL INNOVATION VENTURES SDN.BHD |
ProDetect™ |
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 |
12/11/2021 |
12/11/2022 |
NA |
|
40 |
Epic Science Sdn. Bhd. |
Dymind |
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 |
12/11/2021 |
12/11/2022 |
NA |
|
41 |
Convemed Sdn Bhd |
VivaDiagTM |
VivaDiagTM SARS-CoV-2 Ag Saliva Rapid Test Sample type: Saliva |
VivaCheck Biotech (Hangzhou) Co., Ltd.P.R.China |
VCD17-01-012 |
SE2103162 |
12/11/2021 |
12/11/2022 |
NA |
|
42 |
GEOMICO SDN BHD |
BHM® |
BHM® COVID-19 Antigen Rapid Test Sample type: Nasal swab |
Birmingham Biotech Ltd. England |
BBIO001 |
G2108003 |
17/11/2021 |
17/11/2022 |
NA |
|
43 |
Global Glades Medic Sdn. Bhd. |
GP |
One Step Test for SARS-CoV-2 Antigen (Colloidal Gold) (Saliva) Test Kit Sample type: Saliva |
Getein Biotech Inc. P.R China |
CG20616 |
PSC213031W |
18/11/2021 |
18/11/2022 |
NA |
|
44 |
Teda Wellness Solutions Sdn Bhd |
Raycus |
Raycus COVID-19 Ag Rapid Test Kit - Saliva self-testing Sample type: Saliva |
Anhui Raycus Biological Technology Co., Ltd.P.R.China |
RC2021ST |
C20211001 |
18/11/2021 |
18/11/2022 |
NA |
|
45 |
Jingga Anggun Sdn Bhd |
LONGSEE |
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 |
19/11/2021 |
19/11/2022 |
NA |
|
46 |
Rocky Scientific Instrumentation |
KISSH |
KISSH SARS-CoV-2 Antigen Test Kit (GICA)-Saliva Sample type: Saliva |
Shenzen Kisshealth Biotechnology Co., Ltd.P.R.China |
K602-1S |
20210825 |
19/11/2021 |
19/11/2022 |
NA |
|
47 |
SPD Scientific (M) Sdn Bhd |
V-Chek |
V-Chek 2019-nCoV Antigen Rapid Test Kit (Immunochromatography) Sample type: Nasal swab |
Guangzhou Decheng Biotechnology Co., LTD. P.R. China |
0555C2X001 |
68210701 |
19/11/2021 |
19/11/2022 |
NA |
|
48 |
Rapport Medilines Sdn. Bhd |
GP |
One-step Test for SARS-CoV-2 Antigen (Colloidal Gold) (Saliva) Sample type: Saliva |
Getein Biotech Inc. P.R.China |
CG20616 |
PSC213029W |
19/11/2021 |
19/11/2022 |
NA |
|
49 |
Dyna Source Sdn Bhd |
BioDetect |
BioDetect Rapid SARS-CoV-2 Antigen Test Card (Self-test) Sample type: Nasal swab |
BioDetect (Xiamen) Biotechnology Co., Ltd. P.R.China |
GMT102 |
T220050901 |
19/11/2021 |
19/11/2022 |
NA |
|
50 |
SPD Scientific (M) Sdn. Bhd. |
Green Spring |
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 |
19/11/2021 |
19/11/2022 |
NA |
|
51 |
Watercress Communications Sdn Bhd |
eDiagnosis |
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) |
21070102 |
23/11/2021 |
23/11/2022 |
NA |
|
52 |
K-One MediTech Sdn Bhd |
Medkaire |
Medkaire SARS-CoV-2 Antigen Kit (Saliva) Self-Testing Sample type: Saliva |
Goldsite Diagnostics Inc.P.R.China |
CG123101 |
20210906 |
24/11/2021 |
24/11/2022 |
NA |
|
53 |
N.A.Z Medical Supplies Sdn Bhd |
KONSUNG |
COVID-19 Salivary Antigen Rapid Test Kit (Colloidal Gold) Sample type: Saliva |
Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd.P.R.China |
ICOVS-702G-4 |
S3221072601 |
1/12//2021 |
1/12/2022 |
NA |
|
54 |
TS DIAGNOSTICS SDN BHD |
Forsure |
Forsure COVID-19 Antigen Rapid Test Kit (Oral Fluid) Sample type: Saliva |
TS Diagnostics Sdn Bhd, Taman Perindustrian Puchong, Selangor, Malaysia. |
FS-CV190F-C30 |
2109263 |
1/12//2021 |
1/12/2022 |
NA |
|
55 |
Onecare Biotech Sdn Bhd |
Hongyu |
Hongyu SARS-CoV-2 Rapid Test Kit Sample type: Saliva |
Zhejiang Hongyu Medical Commodity Co., Ltd.P.R.China |
HY-05 |
210820 |
1/12//2021 |
1/12/2022 |
NA |
|
56 |
Teda Wellness Solutions Sdn Bhd |
Lyher |
Lyher Novel Coronavirus (COVID-19) Antigen Test Kit(Colloidal Gold) Sample type: Saliva |
Hangzhou Laihe Biotech Co., Ltd. P.R.China |
303107 |
2108070 |
1/12/2021 |
1/12/2022 |
NA |
|
57 |
Smarttech Engineering and Resource Management Sdn Bhd |
GenFarm |
GenFarm SARS-CoV-2 Antigen Detection Kit Sample type: Nasal swab & Saliva |
Ningbo Lvtang Biotechnology Co., Ltd. P.R.China |
CovAg-NS |
20231017 |
6/12/2021 |
6/12/2022 |
NA |
|
58 |
Symbion Asia Sdn Bhd |
IHealth |
IHealth Novel Coronavirus (SARS-COV-2) Salivary Antigen Rapid Test Kits (Dipstick) Sample type: Saliva |
Symbion Asia Sdn Bhd, Kuala Lumpur, Malaysia |
6000011 |
SE2110030 |
6/12/2021 |
6/12/2022 |
NA |
|
59 |
Prova Lab & Research Sdn Bhd |
Well Biotech |
COVID-19 Ag Rapid Saliva Test Device Sample type: Saliva |
Jiangsu Well Biotech Co., Ltd. P.R.China |
Cat# CO-03S1 |
2108131 |
16/12/2021 |
16/12/2022 |
NA |
|
60 |
Premier Diagnostics Sdn Bhd |
Ecotest |
COVID-19 Antigen Saliva Test Kit Sample type: Saliva |
Assure Tech. (Hangzhou) Co., Ltd. P.R.China. |
COV-S35 |
SR2021090090 |
17/12/2021 |
17/12/2022 |
NA |
|
61 |
Surgical Solutions (M) Sdn Bhd |
Hongyu |
Hongyu SARS-CoV-2 Ag Rapid Test Kit Sample type: Saliva |
Zhejiang Hongyu Medical Commodity Co., Ltd. P.R.China |
HY-05 |
211007 |
17/12/2021 |
17/12/2022 |
NA |
|
62 |
Innotech Healthcare Sdn Bhd |
INNO HEALTH |
COVID-19 Rapid Antigen Saliva Self-Test Kit (Colloidal Gold) Sample type: Saliva |
Bioneovan Co., Ltd. P.R. China |
BG1910C |
202109003 |
17/12/2021 |
17/12/2022 |
NA |
|
63 |
Brands Direct International Sdn Bhd |
Safecare |
Safecare COVID-19 Antigen Rapid Test Kit (Swab) for Self-Testing Sample type: Nasal swab |
Safecare Biotech (Hangzhou) Co., Ltd P.R.China |
COV AG-6012H |
COV21100408 |
17/12/2021 |
17/12/2022 |
NA |
|
64 |
Medical Innovation Ventures Sdn Bhd |
Sejoy® |
Sejoy® SARS-CoV-2 Antigen Saliva Lolly Test Sample type: Saliva |
Hangzhou Sejoy Electronics & Instruments Co., Ltd. P.R.China |
COVG-603 |
21102444 |
21/12/2021 |
21/12/2022 |
NA |
|
65 |
TT Medical Management Sdn Bhd |
SinaDx |
2019-nCoV Antigen Rapid Test (Saliva) (Colloidal Gold) Sample type: Saliva |
Xiamen SinaDx Biomedicals Co., Ltd.P.R.China |
RD0516D1 |
2021100801 |
21/12/2021 |
21/12/2022 |
NA |
|
66 |
Medispec (M) Sdn Bhd |
Watmind |
SARS-CoV-2 Ag Self-Test Kit (Colloidal Gold) Sample type: Saliva |
Shenzhen Watmind Medical Co., Ltd. P.R. China |
LFA0401-1N/5N/25N |
21100604 |
21/12/2021 |
21/12/2022 |
NA |
|
67 |
Medispec (M) Sdn Bhd |
HIGHTOP |
HIGHTOP COVID-19 RTK Antigen Saliva Self-Test (for Home Use) Sample type: Saliva |
Qingdao HighTop Biotech Co., Ltd.P.R.China |
H100S-01 |
COV-1210950 |
22/12/2021 |
22/12/2022 |
NA |
|
68 |
Amcen Lab Sdn Bhd |
AmTest |
AmTest COVID-19 Antigen Detection Kit (Colloidal Gold) Sample type: Saliva |
ZHUHAI LITUO BIOTECHNOLOGY CO. LTD P.R. China |
ACV051 |
20210802 |
23/12/2021 |
23/12/2022 |
NA |
|
69 |
Y.S.P. INDUSTRIES (M) SDN. BHD. |
Chemtrue® |
CHEMTRUE® COVID-19 (SARS-CoV-2) Antigen Rapid Test Kit Sample type: Saliva |
Shanghai Chemtron Biotech Co., Ltd. P.R.China |
8046C |
B202108033 |
29/12/2021 |
29/12/2022 |
NA |
|
70 |
TT Medical Management Sdn Bhd |
KISSH |
KISSH SARS-CoV-2 Antigen Test Kit (GICA) Nasal (Anterior) Sample type: Nasal swab |
Shenzhen Kisshealth Biotechnology Co., Ltd. P.R.China |
K602-1H |
20210727 |
24/12/2021 |
24/12/2022 |
NA |
|
71 |
DW Labs Sdn Bhd |
MEDOMICS |
MEDOMICS SARS-CoV-2 Antigen Test Kit (LFIA) Layman's Test Sample type: Nasal swab |
Jiangsu Medomics Medical Technology Co., Ltd. P.R.China |
1031-14-01 |
20210729 |
24/12/2021 |
24/12/2022 |
NA |
|
72 |
ScienceVision Sdn Bhd |
HUIAN |
SARS-CoV-2 Antigen Test Kit (Colloidal Gold) Sample type: Saliva |
Shenzhen Huian Biosci Technology Co., Ltd. P.R.China |
203-001 / 203-020 |
211001 |
27/12/2021 |
27/12/2022 |
NA |
|
73 |
CLA Medical Sdn Bhd |
GP |
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 CG2061510 CG2061512 CG2061515 CG2061520 CG2061525 |
6SC216040W |
27/12/2021 |
27/12/2021 |
NA |
|
74 |
WYS Trading & Management Consultancy |
GLINE |
GLINE-2019-nCoV Antigen Saliva Sample type: Saliva |
Shenzhen YHLO Biotech Co., Ltd.P.R.China |
G86259 (1T) |
20211001 |
29/12/2021 |
29/12/2022 |
NA |
|
75 |
CLA Medical Sdn Bhd |
GP |
One-Step Test for SARS-CoV-2 Antigen (Colloidal Gold) Self-Test Saliva Sample type: Saliva |
Getein Biotech Inc. P.R.China |
CG20616 CG206162 CG206163 CG206165 CG206166 CG206167 CG206168 CG206169 CG2061610 CG2061612 CG2061615 CG2061620 CG2061625 |
PSC213031W |
29/12/2021 |
29/12/2022 |
NA |
|
76 |
RL Healthcare Sdn Bhd |
Medomics |
SARS-CoV-2 Antigen Test Kit (LFIA) Sample type: Nasal swab |
Jiangsu Medomics Medical Technology Co., Ltd. |
1031-14-01 |
20210729 |
04/01/2022 |
04/01/2023 |
NA |
|
77 |
TOP BIOTECH SDN. BHD. |
TOP RAPID |
COVID-19 Rapid Antigen Home Test Kit (Nasal Swab Specimen) (For Self-Test Use By Non-Professional Users) Sample type: Nasal swab |
TOP BIOTECH SDN BHD |
RTB/COVNsl/AG/3.0/A |
TBCV03008101S |
04/01/2022 |
04/01/2023 |
NA |
|
78 |
Rocky Scientific Instrumentation |
WWHS |
SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) – Saliva Swab Sample type: Saliva |
WWHS Biotech.Inc, P.R. China |
044-2-1T 044-2-5T |
4420210814 |
04/1/2022 |
04/01/2023 |
NA |
|
79 |
Rocky Scientific Instrumentation |
WWHS |
SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) - Nasal (Anterior) Swab Sample type: Nasal swab |
WWHS Biotech.Inc, P.R. China |
044-1-1T 044-1-5T |
4420210814 |
04/1/2022 |
04/01/2023 |
NA |
|
80 |
ANTAH SRI RADIN SDN BHD |
XABT |
2019-nCoV Antigen Rapid Test Cassette For Self-Testing (Saliva Sample) Sample type: Saliva |
Beijing Applied Biological Technologies Co., Ltd. |
CG9041-1T |
E20210826 |
11/1/2022 |
11/1/2023 |
NA |
|
81 |
Medisafe Technologies Sdn Bhd |
COVICHEKTM |
COVICHECK COVID-19 AG SELF TEST Sample type: Saliva |
WIZCHEM CO., LTD. Korea |
CAG301S |
CAG-20210801 |
14/1/2022 |
14/1/2023 |
NA |
|
82 |
Iconic Medicare Sdn Bhd |
Iconic IVD Test Kit |
COVID-19 Antigen Rapid Test Cassette (Nasal Swab/Oral Fluid) Sample Type: Nasal swab or Oral fluid |
Iconic Medicare Sdn Bhd, Penang, Malaysia. |
GCCOV-702a |
2110244 |
17/1/2022 |
17/1/2023 |
NA |
|
83 |
Interscience Sdn Bhd |
StrongStep® |
StrongStep® SARS-CoV-2 Antigen Rapid Test (Self-Test) Sample type: Saliva |
Nanjing Liming Bio-products Co., Ltd. , P.R. China |
500200 |
2108029 |
27/01/2022 |
27/1/2023 |
NA |
|
84 |
Rocky Scientific Sdn Bhd |
KISSH |
SARS-CoV-2 Antigen Test Kit (GICA) – Nasal (Anterior) Swab |
Shenzhen Kisshealth Biotechnology Co., Ltd. P.R.China |
K602-1H, K602-3H, K602-5H |
20210825 |
3/2/2022 |
3/2/2023 |
NA |
|
85 |
EB Holding Sdn Bhd |
HIGIA |
SARS-CoV-2 Antigen Rapid Test Kit Sample type: Nasal swab |
Xiamen Higia Medical Technology Co., Ltd P.R.China |
XJY01950012 |
21091801 |
3/2/2022 |
3/2/2023 |
NA |
|
86 |
Pharmaniaga Marketing Sdn Bhd |
VivaDiag |
VivaDiag™ SARS-CoV-2 Ag Saliva Rapid Test (Lollipop) Sample type: Saliva |
VivaChek Biotech (Hangzhou) Co., Ltd. P.R China |
VCD17-10-019 |
SE2109171 |
10/2/2022 |
10/2/2023 |
NA |
|
87 |
RL Healthcare Sdn Bhd, |
Medomics |
SARS - CoV - 2 Antigen Test Kit (LFIA) for Saliva (Type 1) Sample type: Saliva |
Jiangsu Medomics Medical Technology Co., Ltd. P.R.China |
1031-15-01 |
20210903 |
7/2/2022 |
7/2/2023 |
NA |
|
88 |
MAYSTAR BEAUTY SDN BHD |
Neutrovis |
NeutrovisCOVID-19 Antigen Test Kit (Lateral Chromatography) Sample type: Nasal swab |
H-Guard (China) Co., Ltd. P.R.China |
NTV 117 |
20210905 |
11/2/2022 |
11/2/2023 |
NA |
|
89 |
MAYSTAR BEAUTY SDN BHD |
Neutrovis |
NeutrovisCOVID-19 Antigen Test Kit (Lateral Chromatography) Sample type: Saliva |
H-Guard (China) Co., Ltd. P.R.China |
NTV 121 |
20210923 |
11/2/2022 |
11/2/2023 |
NA |
|
90 |
Solid Intellectual Sdn Bhd |
Diagnos |
COVID-19 Antigen Saliva Test Kit (Colloidal Gold) Sample type: Saliva |
Nantong Diagnos Biotechnology Co., Ltd. P.R.China |
DNS COVID-19 - Ag 003 |
202103011 |
11/2/2022 |
11/2/2023 |
NA |
|
91 |
HWGB Medical Devices & Supplies Sdn Bhd |
Bioneovan |
Covid-19 Antigen Saliva Test Kit (Colloidal Gold) Sample type: Saliva |
Bioneovan Co. Ltd. |
BG1910C |
20210907 |
11/2/2022 |
11/2/2023 |
NA |
|
92 |
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 |
NA |
|
93 |
Himavant Medic (M) Sdn Bhd |
Mylab |
Mylab CoviSelf Covid-19 Rapid Antigen Test Sample Type: Nasal swab |
Mylab Discovery Solutions Pvt., Ltd., India |
MDSC01 |
AG00003-A-062101 |
8/2/2022 |
8/2/2023 |
NA |
|
94 |
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 |
NA |
|
95 |
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 |
NA |
|
96 |
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 |
NA |
|
97 |
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 |
NA |
|
98 |
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 |
NA |
|
99 |
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 |
NA |
|
100 |
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 |
NA |
|
101 |
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 |
NA |
|
102 |
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 |
NA |
|
103 |
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 |
NA |
|
104 |
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 |
NA |
|
105 |
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 |
NA |
|
106 |
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 |
NA |
|
107 |
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 |
NA |
|
108 |
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 |
NA |
|
109 |
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 |
NA |
|
110 |
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 |
NA |
|
111 |
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 |
NA |
|
112 |
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 |
NA |
|
113 |
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 |
NA |
|
114 |
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 |
NA |
|
115 |
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 |
NA |
|
116 |
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 |
NA |
Updated: 26 Mei 2023