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

Diagnostics test reagent / kits NT-proBNP Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000064_94e20b396430c2258f506b17544490b7_40d16cbf1afb54591f4f50cacedc78ee. 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 NT-proBNP Test Kit

UID: MFG/IVD/2022/000064_94e20b396430c2258f506b17544490b7_40d16cbf1afb54591f4f50cacedc78ee

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

NT-proBNP Test Kit (Dry Fluorescence Immunoassay) is intended for in-vitro quantitative measurement of NT-proBNP (Dry Fluorescence Immunoassay) in human serum and plasma. NT-proBNP can be used to evaluate heart contractile, diastolic dysfunction, and ventricular segment wall motion coordination. NT-proBNP is used to indicate heart failure patient at the early stage, determine HF risk levels, monitor medical efficiency of HF drug, evaluate prognosis of HF patient and to distinguish dyspnea that caused by HF from other diseases. Furthermore, NT-proBNP is a risk assessment indicator for Acute Coronary Syndrome (Dry Fluorescence Immunoassay)