HAV IgM ELISA - India CDSCO Medical Device Registration

HAV IgM ELISA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000307_dd3bba9b889001cb5c066a3ad3b0ec30_5b75f06e8ce7a750869b425d51641242. 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 ELISA

UID: IMP/IVD/2019/000307_dd3bba9b889001cb5c066a3ad3b0ec30_5b75f06e8ce7a750869b425d51641242

Brand Name

RecombiLISA

License Holder

Athenese-Dx Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The HAV IgM ELISA is a solid-phase enzyme-linked immunosorbent assay for the qualitative detection of IgM to hepatitis A virus in human serum or plasma. It is intended for professional use only as an aid in the diagnosis of infection with HAV