Cardiac Troponin I Fast Test Kit - India CDSCO Medical Device Registration

Cardiac Troponin I Fast Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000403_f8c7374f2eecc42bbf5948d078992438_32c95a62cff4a699581d2c7a0bc1c226. This device is marketed under the brand name Imumunofluorescence Assay. The license holder is M/s. Reckon Diagnostics Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Cardiac Troponin I Fast Test Kit

UID: IMP/IVD/2019/000403_f8c7374f2eecc42bbf5948d078992438_32c95a62cff4a699581d2c7a0bc1c226

Brand Name

Imumunofluorescence Assay

License Holder

M/s. Reckon Diagnostics Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

Cardiac Troponin I Fast Test Kit (Imumunofluorescence Assay) is intended for in vitro quantitative determination of Cardiac Troponin I (Imumunofluorescence Assay) in serum, plasma or whole blood. This test is used as an aid in the diagnosis of myocardial injury such as Acute Myocardial Infarction (Imumunofluorescence Assay), Unstable Angina, Acute Myocarditis and Acute Coronary Syndrome (Imumunofluorescence Assay)

Class B

CK-MB/cTnI/Myo Fast Test Kit

Brand: Imumunofluorescence Assay

Vector Biotek Pvt Ltd

Class C

Brand: CLIA

Class B