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Mda self test kit - MDA grants conditional approval for self



China ICOVS-702G-4 ICOVS-702G-5 S3221072601 85 TS DIAGNOSTICS SDN BHD Forsure COVID-19 Antigen Rapid Test Kit Oral Fluid Sample type: Saliva TS Diagnostics Sdn Bhd, Taman Perindustrian Puchong, Selangor, Malaysia.

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China R0035 R0037 R0039 20220824 61 Axial Health Sdn.


MDA grants conditional approval for self






China LCV051 20210307 13 Pahang Pharmacy Sdn Bhd GRUENBANKA SARS-CoV-2 Antigen Detection Kit Colloidal Gold Method Sample type: Saliva Ningbo Lvtang Biotechnology Co.






Description: One Step Test for SARS-CoV-2 Antigen Colloidal Gold Saliva Test Kit Sample type: Saliva Getein Biotech Inc.

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Views: 7274 Date: 25.01.2023 Favorited: 72 favorites
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China GF102B1S 20210401 81 Watercress Communications Sdn Bhd eDiagnosis COVID-19 SARS-CoV-2 Antigen Test Kit Sample type: Nasal swab Wuhan EasyDiagnosis Biomedicine Co.
Health Ministry Evaluating Self-Test Kits Meanwhile, Health Minister Khairy Jamaluddin said his ministry had received several complaints regarding Covid-19 self-test kits sold in the market.
China HY-05 210820 87 Teda Wellness Solutions Sdn Bhd Lyher Novel Coronavirus COVID-19 Antigen Test Kit Colloidal Gold Sample type: Saliva Hangzhou Laihe Biotech Co.

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    +116reps
    Medical Device Authority (MDA), Ministry of Health Malaysia, Level 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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    +167reps
    Medical Device Authority (MDA), Ministry of Health Malaysia, Level 6, Prima 9, Prima Avenue II, Block 3547, Persiaran APEC, 63000 Cyberjaya, Selangor, MALAYSIA +603 - 8230 0300 +603 - 8230 0200 : mdb@mda.gov.my
    By: BuiltByUs|||https://www.facebook.com/builtbyus/|||https://twitter.com/builtbyusUK/status/953587488211243008|||https://www.youtube.com/watch?v=008CpFY2hdU
    +385reps
    MDA Guideline Conditional Approval For COVID-19 Rapid Test Kit (Self-Test) (MDA/GL/05). 2. Scope and application This guidance document specifies requirements for conditional approval of Covid-19 RTK (self-test) to be placed in the Malaysian market, based on Circular Letter No.1/2021.
    By: Flogardens|||https://www.facebook.com/flogardens|||https://twitter.com/flogardens_bb|||https://www.youtube.com/channel/UCfbdWJsNQk2IoO9cLHsmqGg
    +235reps
    The Medical Device Authority (MDA) has revoked the conditional approval of two brands of COVID-19 RTK-Ag self-test kits due to failure to comply with the conditions of the approval. The kits in question are the Anhui Deepblue test imported by Innovac Technology Sdn Bhd and the Wiz Biotech test imported by Conan Medical Technology Berhad.
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    +293reps
    MDA chief executive Ahmad Shariff Hambali said so far, two COVID-19 self-test kits had passed the prescribed technical evaluation and performance testing and would be given import and distribution approval in the near future, while another 15 were undergoing performance testing in laboratories before a decision is made.
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