Tn-I Plus - India CDSCO Medical Device Registration

Tn-I Plus is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000365_092542a612bad7cd6cf0eb0cc628f899_2dbcae71e395e68446157c2099216773. 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

Tn-I Plus

UID: IMP/IVD/2021/000365_092542a612bad7cd6cf0eb0cc628f899_2dbcae71e395e68446157c2099216773

Brand Name

AFIAS ST2

License Holder

BODITECH MED INDIA PRIVATE LIMITED

Device Class

Class C

Approving Authority

CDSCO

Product Information

AFIAS Tn-I Plus is a fluorescence Immunoassay ( AFIAS ST2) for the quantitative determination of cardiac troponin-I ( AFIAS ST2) in human whole blood/serum/plasma. It is useful as an aid in management and monitoring of acute myocardial infarction ( AFIAS ST2). For in vitro diagnostic use only

Class C

NT-proBNP

Brand: AFIAS ST2

BODITECH MED INDIA PRIVATE LIMITED

Class C

Brand: AFIAS ST2

Class C