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CDSCO UID MFG/IVD/2022/000056_819e4fc4065c7d634d4bfd19744f00d5_116448fde2d68425f1e33b237bc24ff1

Troponin I Rapid Test

Biotrol Laboratories Pvt. Ltd.·Device Class Class C·India CDSCO
Registration details
UID
MFG/IVD/2022/000056_819e4fc4065c7d634d4bfd19744f00d5_116448fde2d68425f1e33b237bc24ff1
Device class
Class C
License holder
Biotrol Laboratories Pvt. Ltd.
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)
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About this record

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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