CK-MB Rapid Quantitative Test - India CDSCO Medical Device Registration

CK-MB Rapid Quantitative Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000074_323f71ec0cb6b73f74c79c708f454cca_b44134a325764f0df1277a2894a5b699. This device is marketed under the brand name Cardiac Troponin T. The license holder is FINOVA HEALTHCARE 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

CK-MB Rapid Quantitative Test

UID: IMP/IVD/2022/000074_323f71ec0cb6b73f74c79c708f454cca_b44134a325764f0df1277a2894a5b699

Brand Name

Cardiac Troponin T

License Holder

FINOVA HEALTHCARE PRIVATE LIMITED

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Aehealth CK-MB Rapid Test along with Aehealth Fluorescence Immunoassay Analyzer (Cardiac Troponin T) is a fluorescence immunoassay for quantitative measurement of MB Isoenzyme of Creatine Kinase (Cardiac Troponin T) in human whole blood, serum or plasma