Tn-I Plus
- UID
- IMP/IVD/2021/000365_092542a612bad7cd6cf0eb0cc628f899_2dbcae71e395e68446157c2099216773
- Device class
- Class C
- Brand name
- AFIAS ST2
- License holder
- BODITECH MED INDIA PRIVATE LIMITED
- 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
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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