PCT Rapid Quantitative Test - India CDSCO Medical Device Registration

PCT Rapid Quantitative Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000074_780d3ea6c162cae06aaa2689fa22dd56_36b4d192665ff66e7a836f2db62bc2d8. 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

PCT Rapid Quantitative Test

UID: IMP/IVD/2022/000074_780d3ea6c162cae06aaa2689fa22dd56_36b4d192665ff66e7a836f2db62bc2d8

Brand Name

Cardiac Troponin T

License Holder

FINOVA HEALTHCARE PRIVATE LIMITED

Device Class

Class C

Approving Authority

CDSCO

Product Information

The PCT Rapid Quantitative Test along with Aehealth Fluorescence Immunoassay Analyzer(Cardiac Troponin T) is intended for vitro quantitative determination of PCT in human whole blood, serum or plasma. It is mainly used for the auxiliary diagnosis of bacterial infectious diseases, sepsis and septicemia