AFIAS AFP - India CDSCO Medical Device Registration

AFIAS AFP is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000365_c133fe6e81e09a96d0e60dfdacbf287b_9fdda7c59d775e0558dcede257ec60e7. 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

AFIAS AFP

UID: IMP/IVD/2021/000365_c133fe6e81e09a96d0e60dfdacbf287b_9fdda7c59d775e0558dcede257ec60e7

Brand Name

AFIAS ST2

License Holder

BODITECH MED INDIA PRIVATE LIMITED

Device Class

Class C

Approving Authority

CDSCO

Product Information

AFIAS AFP is a fluorescence Immunoassay ( AFIAS ST2) for the quantitative determination of Alpha Feto Protein ( AFIAS ST2) in human whole blood/serum/plasma. It is useful as an aid in management and monitoring of primary hepatocellular carcinoma and non seminomatous testicular cancer

Class C

COVID-19 Ag

Brand: AFIAS ST2

BODITECH MED INDIA PRIVATE LIMITED

Class C

Brand: AFIAS ST2

Class C