NT-proBNP/cTnI Fast Test Kit - India CDSCO Medical Device Registration

NT-proBNP/cTnI Fast Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000403_f52eb97bb8fcff80864707e87d6d5129_1a17034a4b6c5321a93bf0f24fd4b9c8. 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

NT-proBNP/cTnI Fast Test Kit

UID: IMP/IVD/2019/000403_f52eb97bb8fcff80864707e87d6d5129_1a17034a4b6c5321a93bf0f24fd4b9c8

Brand Name

Imumunofluorescence Assay

License Holder

M/s. Reckon Diagnostics Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

NT-proBNP/cTnl Fast Test Ktt (Imumunofluorescence Assay) is intended for in vitro quantitative determination of N-terminal B- type natriuretic peptide precursor/cardiac Troponin I (Imumunofluorescence Assay) in serum, plasma or whole blood. This test is used as an aid in the clinical diagnosis, prognosis and evaluation of Heart Failure (Imumunofluorescence Assay), Acute Myocardial Infarction (Imumunofluorescence Assay) and Acute Coronary Syndrome (Imumunofluorescence Assay)

Class C

T3 Fast Test Kit

Brand: Imumunofluorescence Assay

Vector Biotek Pvt Ltd

Class B

Brand: CLIA

Class B