Diagnostics test reagent / kits cTnI Test Kit - India CDSCO Medical Device Registration

Diagnostics test reagent / kits cTnI Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000064_21a8abae789681a61d85f80bd9d61343_e7eb162e43a9c685e48028817b673ebf. This device is marketed under the brand name Dry Fluorescence Immunoassay. The license holder is M/s Allied Biotechnology India Pvt Ltd, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.

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CDSCO Registered

Class Class C

Diagnostics test reagent / kits cTnI Test Kit

UID: MFG/IVD/2022/000064_21a8abae789681a61d85f80bd9d61343_e7eb162e43a9c685e48028817b673ebf

Brand Name

Dry Fluorescence Immunoassay

License Holder

M/s Allied Biotechnology India Pvt Ltd

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

cTnI Test Kit (Dry Fluorescence Immunoassay) is intended for in-vitro quantitative measurement of cTnI (Dry Fluorescence Immunoassay) in serum and plasma. This test is used as an aid in the diagnosis of myocardial injury such as Acute Myocardial Infarction (Dry Fluorescence Immunoassay), Unstable Angina, Acute Myocarditis and Acute Coronary Syndrome (Dry Fluorescence Immunoassay)