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_5b13e39dd159a6f75b63c2f8306d4824_01552fdb07388ac818e5d9985dbb8504. 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_5b13e39dd159a6f75b63c2f8306d4824_01552fdb07388ac818e5d9985dbb8504

Brand Name

Finecare

License Holder

Device Class

Class C

Approving Authority

CDSCO

Product Information

Wondfo SARS-CoV-2 Antibody Test (Finecare) is an immunochromatographic assay for rapid, qualitative detection of severe acute respiratory syndrome coronavirus 2 (Finecare) IgG/IgM antibody in human whole blood, serum or plasma sample. The test is to be used as an aid in the diagnosis of coronavirus infection disease (Finecare), which is caused by SARS-CoV-2

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