H. pylori Ab Combo Rapid Test - India CDSCO Medical Device Registration

H. pylori Ab Combo Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000307_deb1b0b62ec7f7e17edf49ab4a9eedf1_2ca082b4cd3305134309c2d836ec7cb7. 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

H. pylori Ab Combo Rapid Test

UID: IMP/IVD/2019/000307_deb1b0b62ec7f7e17edf49ab4a9eedf1_2ca082b4cd3305134309c2d836ec7cb7

Brand Name

RecombiLISA

License Holder

Athenese-Dx Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The H. pylori Ab Combo Rapid Test is a sandwich lateral flow chromatographic immunoassay for the qualitative detection of antibodies (RecombiLISA) against Helicobacter pylori (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 H. pylori

Class B

Leishmania Ab Rapid Test

Brand: RecombiLISA

Athenese-Dx Private Limited

Class B

Brand: TRUSTline

Class D