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

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
  • 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 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:

         Expired
         Will be expired soon
          Still Valid
          Application obtained full registration (Act 737) and registration certificate issued (Valid for 5 years)

LIST OF RTK ANTIGEN (SELF-TEST)

List Covid-19 Self-Test Registered

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)

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

8

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

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)


• 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

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
R0037
R0039

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
CG206152
CG206153
CG206155
CG206156
CG206157
CG206158
CG206159
CG2061510
CG2061512
CG2061515
CG2061520
CG2061525

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
CG206162
CG206163
CG206165
CG206166
CG206167
CG206168
CG206169
CG2061610
CG2061612
CG2061615
CG2061620
CG2061625

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
K602-3S
K602-5S

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
CG206162
CG206163
CG206165
CG206166
CG206167
CG206168
CG206169
CG2061610
CG2061612
CG2061615
CG2061620
CG2061625

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)
W-AgH-05S (5 test kits)
W-AgH-01S (1 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
ICOVS-702G-5

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
CG206159

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.
P.R. China

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
12A, Jalan TP 5, Taman Perindustrian UEP, Subang Jaya, Selangor, Malaysia

RTB/COVNsl/AG/3.0/A
RTB/COVNsl/AG/3.0/B

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

Sample Type: 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.
P.R.China

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
20 Tests/kit REF:AKBR4027020
25 Tests/kit REF:AKBR4027025

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)
MCOV-102 (5 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.: 9 September 2022

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  Medical Device Authority (MDA),
Ministry of Health Malaysia,
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Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

  +603 - 8230 0300
  +603 - 8230 0200 
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  • Last Modified: 30 November 2022.
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