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/2019/000074_1aaca6355eca8e7a7324a271b4308404_9e85424917d79ed5158b9e62cc2c1cb8. This device is marketed under the brand name ichroma™. The license holder is Inkarp Instruments 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/2019/000074_1aaca6355eca8e7a7324a271b4308404_9e85424917d79ed5158b9e62cc2c1cb8

Brand Name

ichroma™

License Holder

Inkarp Instruments Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

ichroma™ H. pylori SA (ichroma™) is a fluorescence Immunoassay (ichroma™) 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

Class C

NT-proBNP

Brand: ichroma™

Inkarp Instruments Pvt. Ltd.

Class C

Brand: Diatron

Class B