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 IMP/IVD/2019/000191_b15aab46799c3fae1b16f09c3d5d39c9_378f0cd3b9f1086ffe0ddc404c6d4b0e. This device is marketed under the brand name Finecare. The license holder is Matrix Labs, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

SARS-CoV-2 Antibody Test

UID: IMP/IVD/2019/000191_b15aab46799c3fae1b16f09c3d5d39c9_378f0cd3b9f1086ffe0ddc404c6d4b0e

Brand Name

Finecare

License Holder

Matrix Labs

Device Class

Class C

Approving Authority

CDSCO

Product Information

The FinecareTM SARS-CoV-2 antibody Test is a fluorescence immunoassay used along with FinecareTM FIA Meters (Finecare) for qualitative detection of IgG and IgM antibodies of severe acute respiratory syndrome coronavirus 2 (Finecare) in human serum, plasma and whole blood sample. Clinically, the test is to be used as an aid in the diagnosis of coronavirus infection disease (Finecare), which is caused by SARS-CoV-2