FDA Registration – SARS-CoV-2 Molecular Diagnostic Tests
This Article Deals about FDA Registration for Diagnostic Kits. The approved SARS-CoV-2 molecular diagnostics was published on February 21, 2023 by the Food and Drug Administration, USA. These EUAs have been granted with specific authorization requirements for the manufacturer and accredited […]
Read MoreUS FDA Cancels EUA for Some PPE’S – US FDA Medical Device Regulations
On 30th June, 2021, The US FDA removed the access for COVID-19 related Emergency Market Access for certain types of medical devices and personal protective equipment (PPE) as there has been a greater supply locally for these products. The EUA […]
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Validation of Rapid Antigen Test (RAT) for COVID-19 in India
This article deals with the Validation of Rapid Antigen Test (RAT) for COVID-19. The ICMR invites applications for the validation of the Rapid Antigen Tests (RAT) which is mainly used in the diagnosis and detection of SARS-CoV-2 in India. They […]
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