Troponin I Rapid Test - India CDSCO Medical Device Registration
Troponin I Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000056_819e4fc4065c7d634d4bfd19744f00d5_116448fde2d68425f1e33b237bc24ff1. The license holder is Biotrol Laboratories Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO -North Zone, Ghaziabad.
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License Holder
Biotrol Laboratories Pvt. Ltd.Device Class
Approving Authority
CDSCO -North Zone, Ghaziabad
Product Information
The Troponin I Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of cardiac Troponin I (NA) in human serum, plasma or whole blood. The test has a detection sensitivity of 0.3 ng/mL in human serum/plasma and 0.5 ng/mL in whole blood. It is intended to be used as a screening test by professionals and provides a preliminary test result to aid in the early diagnosis of Acute Myocardial Infarction (NA)
