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Here Are The COVID-19 Self-Test Kits Approved By Medical Device Authority (MDA) Malaysia
Jul 28, 2021
Wondering what type of COVID-19 self-test kits that are available in Malaysia? Well, we hope that this article helps!
Photo via Harian Metro
According to the Medical Device Authority (MDA) Malaysia, the list of these self-test COVID-19 kits that are approved for Conditional Approval based on the decision on the consensus of the COVID-19 Test Kit Expert committee.
All test submissions are scored according to:
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The manufacturer reported clinical and analytical performance evidence
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The evaluation test results from testing facilities are according to the committee evaluation criteria set by Clinical expert panels
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Supporting documents for COVID-19 IVD Test Kits Conditional Approval
Here is the list of all test kits that have been selected with the status as Conditional Approval.
#1 Salixium-COVID-19 Rapid Antigen Rapid Test (Saliva/ Nasal Swab Samples)
Company Name: Reszon Diagnostic International Sdn Bhd
Manufacturer: Reszon Diagnostics International Sdn Bhd. selangor, Malaysia
Detection: RTK-Antigen (Self-test)
Sample Type: Saliva and nasal swab samples (Mix Samples)
#2 Gmate® COVID-19 Ag Saliva for Home Use
Company Name: Reszon Diagnostic International Sdn Bhd
Manufacturer: Reszon Diagnostics International Sdn Bhd. selangor, Malaysia
Detection: RTK-Antigen (Self-test)
Sample Type: Saliva
#3 BERIGHT-COVID-19 Antigen Rapid Test Device (Oral Fluid)
Company Name: Medinics (M) Sdn Bhd
Manufacturer: Hangzhou AllTest Biotech Co., Ltd
Detection: RTK-Antigen (Self-test)
Sample Type: Saliva
#4 ALLTest COVID-19 Antigen Rapid Test (Oral Fluid)
Company Name: Global Science Sdn Bhd
Manufacturer: Hangzhou AllTest Biotech Co., Ltd Zheijang, P.R. China.
Detection: RTK-Antigen (Self-test)
Sample Type: Saliva
#5 JusChek COVID-19 Antigen Rapid Test (Oral Fluid)
Company Name: Neopharma Biotech Asia Sdn Bhd
Manufacturer: Hangzhou AllTest Biotech Co., Ltd Zheijang, P.R. China.
Detection: RTK-Antigen (Self-test)
Sample Type: Saliva
Do remember that these test kits are used for screening purposes ONLY and all test results need further confirmation using RT-PCR.
The test kits can be found at registered pharmacies or private healthcare facilities.
Photo via New Straits Times
According to The Star, Health Minister Dr. Adham Baba said those whose test result is positive are to refer themselves either to a private health facility of the COVID-19 assessment centre or a health clinic, while those whose results come out negative but have symptoms should go to a clinic for evaluation.
If you’re feeling unwell and are showing COVID-19 symptoms, please go get yourself tested!
Take care and stay safe, guys!
By: Aishah Akashah Ahadiat