COVID-19 Ab - India CDSCO Medical Device Registration

COVID-19 Ab is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000074_5ee30e06e669a4b908d7900bb97d4407_61c2a443ad29ad6470d0cb7e2cdf0d18. 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

COVID-19 Ab

UID: IMP/IVD/2019/000074_5ee30e06e669a4b908d7900bb97d4407_61c2a443ad29ad6470d0cb7e2cdf0d18

Brand Name

ichroma™

License Holder

Inkarp Instruments Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

ichroma™ COVID-19 Ab is a fluorescence Immunoassay (ichroma™) for the qualitative determination of IgG/IgM antibodies against 'Novel Coronavirus' in human whole blood /serum/ plasma. It is helpful as an aid in the screening of early mild, asymptomatic or acute patients for identification of 'Novel Coronavirus (ichroma™)' infection with high sensitivity.

Class C

H. pylori SA

Brand: ichroma™

Inkarp Instruments Pvt. Ltd.

Class C

Brand: Diatron

Class B