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_1aaca6355eca8e7a7324a271b4308404_9744c119949f7c10e6bb68669ebf6b90. This device is marketed under the brand name ichroma™ Myoglobin neo. The license holder is CPC DIAGNOSTICS PVT.LTD, 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 SA

UID: IMP/IVD/2022/000198_1aaca6355eca8e7a7324a271b4308404_9744c119949f7c10e6bb68669ebf6b90

Brand Name

ichroma™ Myoglobin neo

License Holder

CPC DIAGNOSTICS PVT.LTD

Device Class

Class B

Approving Authority

CDSCO

Product Information

EZ POC H. pylori SA is a fluorescence immunoassay (ichroma™ Myoglobin 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