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

BNP 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_7b6f9f92285944d736d76c0e313a41e7_db6948e936804193c4908542ed447d9e. 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.

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CDSCO Registered
Class Class C
BNP and Troponin I cardiac marker IVD, kit, fluorescent immunoassay
UID: IMP/IVD/2023/000472_7b6f9f92285944d736d76c0e313a41e7_db6948e936804193c4908542ed447d9e

Brand Name

Quidel Triage® Total 5 Control 2

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Quidel Triage Cardio2 Panel is a fluorescence immunoassay to be used with the Quidel Triage Meters for the rapid quantitative determination of troponin I and B-type natriuretic peptide in EDTA anticoagulated whole blood and plasma specimens. The Quidel Triage Cardio2 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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