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| 12 COVID-19 self-test kits have received conditional approval from the Ministry of Health Malaysia (MOH) through the Medical Devices Authority (MDA) as of August 24, 2021 |
12 COVID -19 self -test kits have received conditional approval - Dr Noor Hisham
24/8/2021
KUALA LUMPUR: A total of 12 COVID-19 self-test kits have received conditional approval from the Ministry of Health Malaysia (MOH) through the Medical Devices Authority (MDA) as of August 24, 2021.
Director -General of Health, Tan Sri Dr Noor Hisham Abdullah said, all the kits can be sold for public use.
The 12 test kits are:
1. Salixium-COVID-19 Rapid Antigen Rapid Test (Saliva/ Nasal Swab Samples)
2. Gmate® COVID-19 Ag Saliva for Home Use
3. BERIGHT-COVID-19 Antigen Rapid Test Device (Oral Fluid)
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style="font-size: medium;">4. ALLTest COVID-19 Antigen Rapid Test (Oral Fluid)
5. JusChek COVID-19 Antigen Rapid Test (Oral Fluid).
6. Longsee 2019-nCoV Ag & Influenza A/B Rapid Co-Detection Kit (Immunochromatography)
7. Sichuan Xincheng SARS-CoV-2 Antigen Assay
8. Flowflex ™ SARS-CoV-2 Antigen Rapid Test (Self-testing)
9. STANDARD ™ Q COVID-19 Ag Saliva Home Test
10. ProDetect ™ COVID-19 Antigen Rapid Self-Test (Saliva)
11. NEWGENE Bioengineering COVID-19 Antigen Detection Kit
12. COVID-19 Antigen Detection Kit (Colloidal Gold) Self Test Kit
Users must also ensure that the COVID-19 self-test kit has obtained import and distribution permission from MDA.
The COVID-19 self-test kit can be purchased at licensed community pharmacies and MDA-approved health facilities.
Sales of COVID-19 self-test kits may be made in the form of individual packs or multi-kit packs and shall meet the labeling requirements.
5. JusChek COVID-19 Antigen Rapid Test (Oral Fluid).
6. Longsee 2019-nCoV Ag & Influenza A/B Rapid Co-Detection Kit (Immunochromatography)
7. Sichuan Xincheng SARS-CoV-2 Antigen Assay
8. Flowflex ™ SARS-CoV-2 Antigen Rapid Test (Self-testing)
9. STANDARD ™ Q COVID-19 Ag Saliva Home Test
10. ProDetect ™ COVID-19 Antigen Rapid Self-Test (Saliva)
11. NEWGENE Bioengineering COVID-19 Antigen Detection Kit
12. COVID-19 Antigen Detection Kit (Colloidal Gold) Self Test Kit
Users must also ensure that the COVID-19 self-test kit has obtained import and distribution permission from MDA.
The COVID-19 self-test kit can be purchased at licensed community pharmacies and MDA-approved health facilities.
Sales of COVID-19 self-test kits may be made in the form of individual packs or multi-kit packs and shall meet the labeling requirements.
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