Troponin I - India CDSCO Medical Device Registration

Troponin I is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000091_4becaa458d21583b89b78e17f06e6712_1d5c126e7693870cb2c6bc9e2da4d85f. This device is marketed under the brand name HUBI PCT. The license holder is MPRS Biological 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

Troponin I

UID: IMP/IVD/2019/000091_4becaa458d21583b89b78e17f06e6712_1d5c126e7693870cb2c6bc9e2da4d85f

Brand Name

HUBI PCT

License Holder

MPRS Biological Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

HUBI-Troponin I is one step in-vitro diagnostic test based on immunochromatography. It must be used with HUBI QUAN pro and designed for quantitative determination of cardiac Troponin I in human whole blood or plasma.