NT-proBNP (AuraFIA NT-proBNP ) - India CDSCO Medical Device Registration

NT-proBNP (AuraFIA NT-proBNP ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000248_5cfcde086c1f486ba00007884db9e372_9261a457d6df97fe6b8ab7188d816cb6. This device is marketed under the brand name Time-resolved Fluorescence Immunochromatographic Assay. The license holder is INDO-MIM TEC PRIVATE LIMITED, 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 (AuraFIA NT-proBNP )

UID: IMP/IVD/2022/000248_5cfcde086c1f486ba00007884db9e372_9261a457d6df97fe6b8ab7188d816cb6

Brand Name

Time-resolved Fluorescence Immunochromatographic Assay

License Holder

INDO-MIM TEC PRIVATE LIMITED

Device Class

Class C

Approving Authority

CDSCO

Product Information

This kit is suitable for in vitro quantitative detection of the concentration of N-terminal Pro-Brain Natriuretic Peptide (Time-resolved Fluorescence Immunochromatographic Assay) in human serum, plasma and whole blood. This product is used for testing in medical and health institutions as an aid in the diagnosis of heart failure and its prognosis

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