CK-MB/cTnI/Myo Fast Test Kit - India CDSCO Medical Device Registration

CK-MB/cTnI/Myo Fast Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000410_66cbe1a7376c45ee3d268da5f4979ae9_440c29812bd2d7bf2cdeec5fdcc7d4e4. This device is marketed under the brand name Imumunofluorescence Assay. The license holder is Vector Biotek 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

CK-MB/cTnI/Myo Fast Test Kit

UID: IMP/IVD/2019/000410_66cbe1a7376c45ee3d268da5f4979ae9_440c29812bd2d7bf2cdeec5fdcc7d4e4

Brand Name

Imumunofluorescence Assay

License Holder

Vector Biotek Pvt Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

CK-MB/cTnl/Myo Fast Test Kit (Imumunofluorescence Assay) is intended for in vitro quantitative determination of CK-MB/cTnl/ Myo in serum, plasma or whole blood. This test is used as an aid in the clinical diagnosis, prognosis and evaluation of myocardial injury such as Acute Myocardial Infarction (Imumunofluorescence Assay), Unstable Angina, Acute Myocarditis and Acute Coronary Syndrome (Imumunofluorescence Assay)

Class B

NT-proBNP Fast Test Kit

Brand: Imumunofluorescence Assay

Vector Biotek Pvt Ltd

Class C

Brand: MAGLUMI

Class B