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/2020/000290_2c97e2d9773176b6fd9b8a27ae0a3400_f7aae18ff410a21f24819f1764616320. This device is marketed under the brand name Lateral Flow Method. The license holder is INVEX HEALTH PRIVATE LIMITED, 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/2020/000290_2c97e2d9773176b6fd9b8a27ae0a3400_f7aae18ff410a21f24819f1764616320

Brand Name

Lateral Flow Method

License Holder

INVEX HEALTH PRIVATE LIMITED

Device Class

Class C

Approving Authority

CDSCO

Product Information

Wondfo SARS-CoV-2 Antibody Test (Lateral Flow Method) is an immunochromatographic assay for rapid, qualitative detection of severe acute respiratory syndrome coronavirus 2 (Lateral Flow Method) 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 (Lateral Flow Method), which is caused by SARS-CoV-2. The test provides preliminary test results. Negative results don’t preclude SARS-CoV-2 infection and they cannot be used as the sole basis for treatment or other management decision.