Troponin I test - India CDSCO Medical Device Registration
Troponin I test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000085_25c7d9aebb9c785077e83c6b15ab6a81_12e75ec4a0bbcf0840fc50978fe43406. This device is marketed under the brand name Pratham ®. The license holder is M/s ASTAM DIAGNOSTICS PVT. LTD., and it is classified as Device Class Class C. The approving authority is CDSCO -North Zone, Ghaziabad.
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Brand Name
Pratham ®
License Holder
M/s ASTAM DIAGNOSTICS PVT. LTD.Device Class
Approving Authority
CDSCO -North Zone, Ghaziabad
Product Information
Troponin-I is an in vitro diagnostic test based on immunochromatographic assay. It is designed for qualitative determination of Cardiac Troponin-I (Pratham ®) in human serum / plasma/ Whole blood as an aid in the diagnosis of acute myocardial infarction (Pratham ®).
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