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BNP, CK-MB and Troponin I cardiac marker IVD, kit, fluorescent immunoassay - India CDSCO Medical Device Registration

BNP, CK-MB and Troponin I cardiac marker IVD, kit, fluorescent immunoassay is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000472_466a3ec8cf5319b46685dc3f7eb9e682_77eaed54fa03281e5c1cb40fb376224f. This device is marketed under the brand name Quidel Triage® Total 5 Control 2. The license holder is M/s. Ortho Clinical 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.

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CDSCO Registered
Class Class C
BNP, CK-MB and Troponin I cardiac marker IVD, kit, fluorescent immunoassay
UID: IMP/IVD/2023/000472_466a3ec8cf5319b46685dc3f7eb9e682_77eaed54fa03281e5c1cb40fb376224f

Brand Name

Quidel Triage® Total 5 Control 2

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Quidel Triage Cardio3 Panel is a fluorescence immunoassay to be used with the Quidel Triage Meters for the quantitative determination of creatine kinase MB, troponin I, and B-type natriuretic peptide in EDTA anticoagulated whole blood and plasma specimens. The Quidel Triage Cardio3 Panel is to be used as an aid in the diagnosis of myocardial infarction (Quidel Triage® Total 5 Control 2), an aid in the diagnosis and assessment of severity of congestive heart failure (Quidel Triage® Total 5 Control 2), an aid in the risk stratification of patients with heart failure, and an aid in the risk stratification of patients with acute coronary syndromes

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