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

Filariasis 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_71990b3baf8e432c978966fa21ffd0ce_41e4dd370a9ad83fbf575785dc1fab6c. 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

Filariasis IgG/IgM Combo Rapid Test

UID: IMP/IVD/2019/000307_71990b3baf8e432c978966fa21ffd0ce_41e4dd370a9ad83fbf575785dc1fab6c

Brand Name

RecombiLISA

License Holder

Athenese-Dx Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Filariasis IgG/IgM Combo Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM antibodies to lymphatic filarial parasites (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 lymphatic filarial parasites

Class B

HAV IgG/IgM Rapid Test

Brand: RecombiLISA

Athenese-Dx Private Limited

Class B

Brand: TRUSTline

Class D