HAV IgG/IgM Rapid Test - India CDSCO Medical Device Registration

HAV IgG/IgM Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000307_c9e9cea646184e2f01be3dcbb33480b2_09c30a825b996f6a2a8c4b813665e4a3. This device is marketed under the brand name RecombiLISA. The license holder is Athenese-Dx Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

HAV IgG/IgM Rapid Test

UID: IMP/IVD/2019/000307_c9e9cea646184e2f01be3dcbb33480b2_09c30a825b996f6a2a8c4b813665e4a3

Brand Name

RecombiLISA

License Holder

Athenese-Dx Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The HAV IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of antibodies (RecombiLISA) to Hepatitis A virus (RecombiLISA) in human serum, plasma or whole blood. It is intended to be used as a screening test by professionals and provide a preliminary result to aid in the diagnosis of active and/or past HAV infection

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Brand: TRUSTline

Class D