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D-dimer IVD. reagent - India CDSCO Medical Device Registration

D-dimer IVD. reagent is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000077_ade37eed9ce18c2cd2d49f01152702f2_fb96e8491d18e3bd811c26a4f7f33987. This device is marketed under the brand name Quidel Triage® Total 3 Control 1. The license holder is M/s Parekh Integrated Services Pvt. Ltd., 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.

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CDSCO Registered
Class Class C
D-dimer IVD. reagent
UID: IMP/IVD/2020/000077_ade37eed9ce18c2cd2d49f01152702f2_fb96e8491d18e3bd811c26a4f7f33987

Brand Name

Quidel Triage® Total 3 Control 1

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Quidel Triage D-Dimer Test is a fluorescence immunoassay to be used with the Quidel Triage Meters for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens. The test is used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism

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