H. Pylori SA
- UID
- IMP/IVD/2022/000198_f971f75e362124120aab70e9563949a9_8359a4d4347500a6e8f8c867abbe9b50
- Device class
- Class C
- Brand name
- iChroma Tn-1 Neo
- License holder
- CPC DIAGNOSTICS PVT.LTD
- 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
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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