For those who are looking for Covid-19 Self-Test kit, below is the list of all tests that have been selected to date and the status is Conditional Approval by MDA – Medical Device Authority Malaysia


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.
1Reszon Diagnostic International Sdn BhdSalixium-COVID-19 Rapid Antigen Rapid Test (Saliva/ Nasal Swab Samples)Reszon Diagnostics International Sdn Bhd. selangor, MalaysiaSLXHB1-0621001RTK-Antigen (Self-test)Saliva and nasal swab samples (Mix Samples)
2Citymedic Sdn BhdGmate® COVID-19 Ag Saliva for Home UsePhilosys Co., Ltd, Republic of KoreaAG-020RTK-Antigen (Self-test)Saliva
3Medinics (M) Sdn BhdBERIGHT-COVID-19 Antigen Rapid Test Device (Oral Fluid)Hangzhou AllTest Biotech Co., Ltd. Zheijang, P.R. ChinaICOV-802HRTK-Antigen (Self-test)Saliva
4Global Science Sdn BhdALLTest COVID-19 Antigen Rapid Test (Oral Fluid)Hangzhou AllTest Biotech Co., Ltd Zheijang, P.R. China.ICOV-802HRTK-Antigen (Self-test)Saliva
5Neopharma Biotech Asia Sdn BhdJusChek COVID-19 Antigen Rapid Test (Oral Fluid)Hangzhou AllTest Biotech Co., Ltd Zheijang, P.R. China.ICOV-802HRTK-Antigen (Self-test)Saliva
6Jingga Anggun Sdn BhdLongsee 2019-nCoV Ag & Influenza A/B Rapid Co-Detection Kit (Immunochromatography) Home based UseGuangdong Longsee Biomedical Co. Ltd.,Guangzhou,P.R. ChinaLS-C-T-005RTK-Antigen (Self-test)Saliva
7Hexamine Sdn BhdSichuan Xincheng SARS-CoV-2 Antigen AssaySichuan Xincheng Biological Co. Ltd., P.R. China.T4001WRTK-Antigen (Self-test)Nasal swab
8Translab (M) Sdn BhdFlowflex™ SARS-CoV-2 Antigen Rapid Test (Self-testing)ACON Biotech (Hangzhou) Co., Ltd., P.R.ChinaL031-118M5RTK-Antigen (Self-test)Nasal swab
9Neoscience Sdn BhdSTANDARD™ Q COVID-19 Ag Saliva Home TestSD Biosensor, Inc. Republic of KoreaRef No: Q-NCOV-02G Cat. No: 09COV131RTK-Antigen (Self-test)Saliva
10Medical Innovation Ventures Sdn BhdProDetect™ COVID-19 Antigen Rapid Self-Test (Saliva)Medical Innovation Ventures Sdn Bhd, Penang, MalaysiaPR-CVDCAgSRTK-Antigen (Self-test)Saliva
11Dewina Consult Sdn BhdNEWGENE Bioengineering COVID-19 Antigen Detection KitNew Gene (Hangzhou) Bioengineering Co., Ltd. P.R. ChinaCOVID-19-NG08RTK-Antigen (Self-test)Saliva or Nasal swab
12Tree Med Sdn BhdLituo COVID-19 Antigen Detection Kit (Colloidal Gold) Self Test KitZhuhai Lituo Biotechnology Co., Ltd. P. R. ChinaLCV051RTK-Antigen (Self-test)Saliva
13Pahang Pharmacy Sdn BhdGRUENBANKA SARS-CoV-2 Antigen Detection Kit (Colloidal Gold Method)Ningbo Lvtang Biotechnology Co. Ltd., Zhejiang P.R, China.JQ-nCovAg-SRTK-Antigen (Self-test)Saliva
14Malaysian Diagnostics Corporation Sdn BhdHumasis COVID-19 Ag Home Test (Self-Test)Humasis Co. Ltd.,

Republic of Korea.
ACOVAGS-7025RTK-Antigen (Self-test)Nasal swab

Updated 30 August 2021