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

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

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.

This test kit can be supplied by registered pharmacists or private healthcare facilities.

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.

*  Self Test Kit COVID-19 IS FOR SALE/ PURCHASE AT LICENSED PHARMACIES AND CLINICS ONLY 

NO

COMPANY NAME

PRODUCT NAME

MANUFACTURER

IDENTIFIER

DETECTION

SAMPLE TYPE

1

Reszon Diagnostic International Sdn Bhd

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

Reszon Diagnostics International Sdn Bhd. selangor, Malaysia

SLXHB1-0621001

RTK-Antigen (Self-test)

Saliva and nasal swab samples (Mix Samples)

2

Citymedic Sdn Bhd

Gmate® COVID-19 Ag Saliva for Home Use

Philosys Co., Ltd, Republic of Korea

AG-020

RTK-Antigen (Self-test)

Saliva

3

Medinics (M) Sdn Bhd

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

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

ICOV-802H

RTK-Antigen (Self-test)

Saliva

4 Global Science Sdn Bhd ALLTest COVID-19 Antigen Rapid Test (Oral Fluid) Hangzhou AllTest Biotech Co., Ltd Zheijang, P.R. China. ICOV-802H RTK-Antigen (Self-test) Saliva
5 Neopharma Biotech Asia Sdn Bhd JusChek COVID-19 Antigen Rapid Test (Oral Fluid) Hangzhou AllTest Biotech Co., Ltd Zheijang, P.R. China. ICOV-802H RTK-Antigen (Self-test) Saliva
6 Jingga Anggun Sdn Bhd Longsee 2019-nCoV Ag & Influenza A/B Rapid Co-Detection Kit (Immunochromatography) Home based Use Guangdong Longsee Biomedical Co. Ltd.,Guangzhou,P.R. China LS-C-T-005 RTK-Antigen (Self-test) Saliva
7 Hexamine Sdn Bhd Sichuan Xincheng SARS-CoV-2 Antigen Assay Sichuan Xincheng Biological Co. Ltd., P.R. China. T4001W RTK-Antigen (Self-test) Nasal swab
8 Translab (M) Sdn Bhd Flowflex™ SARS-CoV-2 Antigen Rapid Test (Self-testing) ACON Biotech (Hangzhou) Co., Ltd., P.R.China L031-118M5 RTK-Antigen (Self-test) Nasal swab
9 Neoscience Sdn Bhd STANDARD™ Q COVID-19 Ag Saliva Home Test SD Biosensor, Inc. Republic of Korea

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

RTK-Antigen (Self-test) Saliva
10 Medical Innovation Ventures Sdn Bhd ProDetect™ COVID-19 Antigen Rapid Self-Test (Saliva) Medical Innovation Ventures Sdn Bhd, Penang, Malaysia PR-CVDCAgS RTK-Antigen (Self-test)

Saliva

11 Dewina Consult Sdn Bhd NEWGENE Bioengineering COVID-19 Antigen Detection Kit New Gene (Hangzhou) Bioengineering Co., Ltd. P.R. China COVID-19-NG08 RTK-Antigen (Self-test) Saliva or Nasal swab
12 Tree Med Sdn Bhd Lituo COVID-19 Antigen Detection Kit (Colloidal Gold) Self Test Kit Zhuhai Lituo Biotechnology Co., Ltd. P. R. China LCV051 RTK-Antigen (Self-test) Saliva
13 Pahang Pharmacy Sdn Bhd GRUENBANKA SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method) Ningbo Lvtang Biotechnology Co. Ltd., Zhejiang P.R, China. JQ-nCovAg-S RTK-Antigen (Self-test) Saliva
14 Malaysian Diagnostics Corporation Sdn Bhd Humasis COVID-19 Ag Home Test (Self-Test)

Humasis Co. Ltd., Republic of Korea.

ACOVAGS-7025 RTK-Antigen (Self-test) Nasal swab
15 Teda Wellness Solutions Sdn Bhd LYHER® Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)

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

30306 RTK-Antigen (Self-test) Nasal swab
16 N.A.Z. Medical Supplies Sdn Bhd

ALLTEST COVID-19 Antigen Rapid Test

(Oral Fluid)

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

ICOV-802H RTK-Antigen (Self-test) Saliva
17

Medinics (M) Sdn Bhd

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

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

INCP-502H RTK-Antigen (Self-test)

Nasal swab

18 Roche Diagnostics (M) Sdn Bhd Roche SARS-CoV-2 Antigen Self-Test Nasal

SD Biosensor, Republic of Korea.

9901-NCOV-06G / 09445323077 RTK-Antigen (Self-test) Nasal swab
19 Onecare Biotech Sdn Bhd ARISTA™ COVID-19 Antigen Rapid Test ARISTA Biotech Pte. Ltd., Singapore. ARISTA-AG-L1EN-001 ARISTA-AG-L1MY-001 RTK-Antigen (Self-test) Nasal swab

Updated 21 September 2021

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

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  • Kemaskini Terakhir: 22 September 2021.
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