SARS-CoV-2 Antibody Test - India CDSCO Medical Device Registration
SARS-CoV-2 Antibody Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000073_b15aab46799c3fae1b16f09c3d5d39c9_8844a4691715dc6665319425dd08d416. This device is marketed under the brand name CovAbScreen / CovAb. The license holder is Diabetomics Medical (P) Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO, Zonal office, Hyderabad.
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Brand Name
CovAbScreen / CovAb
License Holder
Diabetomics Medical (P) LtdDevice Class
Approving Authority
CDSCO, Zonal office, Hyderabad
Product Information
The CovAbScreenTM SARS-CoV-2 Ab Test is a lateral flow immunoassay intended for qualitative detection of total antibodies (CovAbScreen / CovAb) to SARS-CoV-2 in oral fluid specimen (CovAbScreen / CovAb)
