HAV IgM Rapid Test - India CDSCO Medical Device Registration

HAV IgM Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000307_f0c8e247aa7de545890a48f59be360de_10c322f6df7db29596ee036947d5ef34. 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 IgM Rapid Test

UID: IMP/IVD/2019/000307_f0c8e247aa7de545890a48f59be360de_10c322f6df7db29596ee036947d5ef34

Brand Name

RecombiLISA

License Holder

Athenese-Dx Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

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

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HAV IgM Rapid Test

Biotrol Laboratories Pvt. Ltd.

Class B

Brand: RecombiLISA

Athenese-Dx Private Limited

Class B

Brand: TRUSTline

Class D