CRP - India CDSCO Medical Device Registration

CRP is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000365_68e5ed3321d8b86d30dd340193dc3716_96a7e89eb1bcdecd7197f66d80cc4aa6. This device is marketed under the brand name AFIAS ST2. The license holder is BODITECH MED INDIA PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

CRP

UID: IMP/IVD/2021/000365_68e5ed3321d8b86d30dd340193dc3716_96a7e89eb1bcdecd7197f66d80cc4aa6

Brand Name

AFIAS ST2

License Holder

BODITECH MED INDIA PRIVATE LIMITED

Device Class

Class C

Approving Authority

CDSCO

Product Information

AFIAS CRP is a fluorescence Immunoassay ( AFIAS ST2) for the quantitative determination of C-Reactive Protein ( AFIAS ST2) in human whole blood/serum/plasma. It is useful as an aid in management and monitoring of autoimmune diseases and infectious processes, such as rheumatoid arthritis. For in vitro diagnostic use only

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CRP

Brand: AFIAS ST2

Class C