H. Pylori SA - India CDSCO Medical Device Registration

H. Pylori SA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000198_f971f75e362124120aab70e9563949a9_8359a4d4347500a6e8f8c867abbe9b50. This device is marketed under the brand name iChroma Tn-1 Neo. The license holder is CPC DIAGNOSTICS PVT.LTD, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

H. Pylori SA

UID: IMP/IVD/2022/000198_f971f75e362124120aab70e9563949a9_8359a4d4347500a6e8f8c867abbe9b50

Brand Name

iChroma Tn-1 Neo

License Holder

CPC DIAGNOSTICS PVT.LTD

Device Class

Class C

Approving Authority

CDSCO

Product Information

ichromaTM H. pylori SA (iChroma Tn-1 Neo) is a fluorescence immunoassay (iChroma Tn-1 Neo) for the qualitative determination of H. pylori antigen in human feces. It is useful as an aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori antigen following treatment