AFIAS Troponin T - India CDSCO Medical Device Registration

AFIAS Troponin T is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000365_95b9f89ccf8907d62b26ffe0d5d43b3c_db52eb0e11fb07efbadf889e38230dbf. 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 Troponin T

UID: IMP/IVD/2021/000365_95b9f89ccf8907d62b26ffe0d5d43b3c_db52eb0e11fb07efbadf889e38230dbf

Brand Name

AFIAS ST2

License Holder

BODITECH MED INDIA PRIVATE LIMITED

Device Class

Class C

Approving Authority

CDSCO

Product Information

AFIAS Troponin T is a fluorescence Immunoassay ( AFIAS ST2) for the quantitative determination of Troponin T level in human whole blood/serum/plasma. It is useful as an aid in management and monitoring of acute myocardial infarction ( AFIAS ST2)

Class C

COVID-19 Ag

Brand: AFIAS ST2

BODITECH MED INDIA PRIVATE LIMITED

Class C

Brand: AFIAS ST2

Class C