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Multiple cardiac marker IVD, kit, fluorescent immunoassay - India CDSCO Medical Device Registration

Multiple cardiac marker IVD, kit, fluorescent immunoassay is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000077_afab7778696a60cf9107648f8548d9f2_f9b03850a9d0996270e888f5e4d39c5f. 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
Multiple cardiac marker IVD, kit, fluorescent immunoassay
UID: IMP/IVD/2020/000077_afab7778696a60cf9107648f8548d9f2_f9b03850a9d0996270e888f5e4d39c5f

Brand Name

Quidel Triage® Total 3 Control 1

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Quidel Triage Profiler SOB (Quidel Triage® Total 3 Control 1) Panel is a fluorescence immunoassay to be used with the Quidel Triage Meters for the quantitative determination of creatine kinase MB, myoglobin, troponin I, B‐type natriuretic peptide, and 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 diagnosis of myocardial infarction (Quidel Triage® Total 3 Control 1), an aid in the diagnosis and assessment of severity of heart failure, an aid in the risk stratification of patients with heart failure, an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism and an aid in the risk stratification of patients with acute coronary syndromes

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