H. pylori SA
- UID
- IMP/IVD/2019/000074_1aaca6355eca8e7a7324a271b4308404_9e85424917d79ed5158b9e62cc2c1cb8
- Device class
- Class C
- Brand name
- ichroma™
- License holder
- Inkarp Instruments Pvt. Ltd.
- 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
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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