D-Dimer - India CDSCO Medical Device Registration

D-Dimer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000203_1626e5dadf42ed68ee03464b54ef86b3_765e260b4579690cfc0141249c96dd94. This device is marketed under the brand name QDx Instacheck™ AFP. The license holder is DiaSys Diagnostics India Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

CDSCO Registered

Class Class C

D-Dimer

UID: IMP/MD/2018/000203_1626e5dadf42ed68ee03464b54ef86b3_765e260b4579690cfc0141249c96dd94

Brand Name

QDx Instacheck™ AFP

License Holder

DiaSys Diagnostics India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

QDx Instacheck™ D-Dimer is a fluorescence Immunoassay (QDx Instacheck™ AFP) for the quantitative determination of D-Dimer in human whole blood / plasma. It is useful as an aid in management and monitoring of post therapeutic evaluation of thromboembolic disease patients. For in vitro diagnostic use only