Troponin I - India CDSCO Medical Device Registration
Troponin I is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000420_d989a455def0776258389bc5c9c47107_73dfda5cd54b3ae403f26f43acfe6e53. This device is marketed under the brand name Electro chemiluminescence Immunoassay. The license holder is M/S Agappe Diagnostics Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
Electro chemiluminescence Immunoassay
License Holder
M/S Agappe Diagnostics LtdDevice Class
Approving Authority
CDSCO
Product Information
Immunoassay for in vitro quantitative determination of cardiac troponin I in human serum and plasma. This assay is intended to auxiliary diagnosis of myocardial infarction
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