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/2020/000059_092542a612bad7cd6cf0eb0cc628f899_a207e93d9a4953dca936e501dc17432b. This device is marketed under the brand name ichroma™ ST2. The license holder is Kin Diagnostics, and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
ichroma™ ST2
License Holder
Kin DiagnosticsDevice Class
Approving Authority
CDSCO
Product Information
ichroma™ Tn-I Plus is a Fluorescence Immunoassay (ichroma™ ST2) for the quantitative determination of cardiac troponin-I (ichroma™ ST2) in human whole blood/serum/plasma. It is useful as an aid in management and monitoring of acute myocardial infarction (ichroma™ ST2). For in vitro diagnostic use only
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