Leptospira IgG/IgM Combo Rapid Test - India CDSCO Medical Device Registration

Leptospira IgG/IgM Combo Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000307_e56c33e47d08fc82c7bd8d48235a4b4e_5ca36fcd043bdcf944144bf7f4e0430e. 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

Leptospira IgG/IgM Combo Rapid Test

UID: IMP/IVD/2019/000307_e56c33e47d08fc82c7bd8d48235a4b4e_5ca36fcd043bdcf944144bf7f4e0430e

Brand Name

RecombiLISA

License Holder

Athenese-Dx Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Leptospira IgG/IgM Combo Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM antibodies to Leptospira interrogans (RecombiLISA) in human serum, plasma or whole blood. It is intended to be used as a screening test by professionals, and provides a preliminary test result to aid in the diagnosis of infection with L. interrogans

Class B

Leishmania Ab Rapid Test

Brand: RecombiLISA

Athenese-Dx Private Limited

Class B

Brand: TRUSTline

Class D