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/2020/000323_5b13e39dd159a6f75b63c2f8306d4824_09edac80561c158b2a3cb72c7e013a81. This device is marketed under the brand name Lateral Flow Method. The license holder is Trivitron Healthcare Pvt. Ltd., 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/2020/000323_5b13e39dd159a6f75b63c2f8306d4824_09edac80561c158b2a3cb72c7e013a81

Brand Name

Lateral Flow Method

License Holder

Trivitron Healthcare Pvt. Ltd.

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.