Pure Global

Troponin I IVD, kit, fluorescent immunoassay - India CDSCO Medical Device Registration

Troponin I IVD, kit, fluorescent immunoassay is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000077_e920296fa1e52bbb4411daca8cb851e8_f618c8282ef871086a9c5002bfe109f8. 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.

Free Database
Powered by Pure Global AI
CDSCO Registered
Class Class C
Troponin I IVD, kit, fluorescent immunoassay
UID: IMP/IVD/2020/000077_e920296fa1e52bbb4411daca8cb851e8_f618c8282ef871086a9c5002bfe109f8

Brand Name

Quidel Triage® Total 3 Control 1

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Quidel TriageTrue High Sensitivity Troponin I Test is a fluorescence immunoassay to be used with the Triage® MeterPro for the quantitative determination of troponin I in EDTA anticoagulated whole blood and plasma specimens. The test is to be used as an aid in the diagnosis of myocardial infarction. (Quidel Triage® Total 3 Control 1)

Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing