D-Dimer Rapid Quantitative Test - India CDSCO Medical Device Registration

D-Dimer Rapid Quantitative Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000074_28d2afab4685c3a2fbec7c69494f6bfc_5a6261c9085605d4c52e7160fd262e2e. 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

D-Dimer Rapid Quantitative Test

UID: IMP/IVD/2022/000074_28d2afab4685c3a2fbec7c69494f6bfc_5a6261c9085605d4c52e7160fd262e2e

Brand Name

Cardiac Troponin T

License Holder

FINOVA HEALTHCARE PRIVATE LIMITED

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Aehealth D-Dimer Rapid Quantitative Test is based on fluorescence immunoassay technology. The Aehealth D-Dimer Rapid Quantitative Test uses a sandwich immunodetection method, when sample is added to the sample well of the Test Cassette, the fluorescence-labeled detector D-Dimer antibody binds to D-Dimer antigen in blood specimen. As the sample mixture migrates on the nitrocellulose matrix of test strip by capillary action, the complexes of detector antibody and D-Dimer are captured to D-Dimer antibody that has been immobilized on test strip. Thus the more D-Dimer antigen is in blood specimen, the more complexes are accumulated on test strip. Signal intensity of fluorescence of detector antibody reflects amount of D-Dimer captured and Aehealth FIA Meter shows D-Dimer concentrations in blood specimen