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

logo mda login admin min

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

BRAND

PRODUCT NAME

MANUFACTURER

IDENTIFIER

LOT NUMBER

1

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

2

Citymedic Sdn Bhd

Gmate®

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

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

JusChek COVID-19 Antigen Rapid Test (Oral Fluid)

Sample type: Saliva

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

ICOV-802H

ATCOV21060078

5

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

6

Jingga Anggun Sdn Bhd

Longsee

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 (Diacegene)

Sichuan Xincheng (Diacegene) 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™

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™

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™

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

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

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

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

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®

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

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™

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

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™

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™

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

21

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

22

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

23

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

24

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

25

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

26

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

27

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

28

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

29

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

30

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

31

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

32

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

33

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

34

PMAN Healthcare Specialist Sdn Bhd

Ninonasal®

Ninonasal® Self-Test

Sample type: Nasal swab

NG Biotech Laboratories, France

NGB-COV-S23-302

210305-01-E

35

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

36

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

37

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

38

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

39

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

40

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

41

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

42

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

43

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

44

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

45

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

46

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

47

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

48

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

49

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

50

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

51

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

52

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

53

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

54

EB Holdings Sdn Bhd

Sugentech

SGTi-flex COVID-19 Antigen

Sample type: Nasal swab

Sugentech INC Korea

CAGT001E0

CAGT002E0

CAGT005E0

CAGS21001

55

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

56

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

57

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

58

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

59

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

60

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

61

Axial Health Sdn. Bhd.

Axial Health

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

Sample type: Saliva

WFR Medical Supplies SDN BHD,Penang, Malaysia

AX-V100

2021061504

62

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

63

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

64

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

65

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

66

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

67

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

68

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

69

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

70

GEOMICO SDN BHD

BHM®

BHM® COVID-19 Antigen Rapid Test

Sample type: Nasal swab

Birmingham Biotech Ltd. England

BBIO001

G2108003

71

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

72

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

73

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

74

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

75

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

76

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

77

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

78

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

79

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

80

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

81

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

82

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

83

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

84

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

85

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

86

Multiplex Enterprise

Eagle Bio

Eagle Bio SARS-CoV-2 Antigen IVD Kit Lollipop (Self Testing)

Sample type: Saliva

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

HN06

20210902-01

87

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

88

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

89

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

90

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

91

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

92

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

93

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

94

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

95

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

96

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

97

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

98

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

99

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

100

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

101

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

102

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

103

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

104

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

105

WYS Trading & Management Consultancy

GLINE

GLINE-2019-nCoV Antigen Saliva

Sample type: Saliva

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

G86259 (1T)

20211001

106

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

107

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

108

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

109

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

110

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

111

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

112

Medisafe Technologies Sdn Bhd

COVICHEKTM

COVICHECK COVID-19 AG SELF TEST

Sample type: Saliva

WIZCHEM CO., LTD. Korea

CAG301S

CAG-20210801

113

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

114

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

115

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

116

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

117

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

118

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

119

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

120

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

121

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

122

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

123

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

124

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

125

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

126

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

127

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

128

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

129

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

130

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

131

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

132

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

133

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

134

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

135

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

136

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

137

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

138

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

139

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

140

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

141

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

 

Updated.: 14th June 2022

Cetak

  Pihak Berkuasa Peranti Perubatan Malaysia,
Kementerian Kesihatan Malaysia,
Aras 6, Prima 9, Prima Avenue II,
Block 3547, Persiaran APEC,
63000 Cyberjaya, Selangor, MALAYSIA

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

Today 2497 Yesterday 3545 Week 12989 Month 22124 Jumlah Pengunjung: 112850795

  • Kemaskini Terakhir: 07 Julai 2022.
facebooktwitterinstagramyoutube
Copyright © 2022 Medical Device Authority
Ministry of Health Malaysia
Best view with Firefox 64 and above, minimum resolution 1366x768