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B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit,fluorescent immunoassay - India CDSCO Medical Device Registration

B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit,fluorescent immunoassay is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000472_b388c5729cf5e0bf917d5e2ae5242440_f01d1bbe14946ca767ac89b9078a3c93. 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
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit,fluorescent immunoassay
UID: IMP/IVD/2023/000472_b388c5729cf5e0bf917d5e2ae5242440_f01d1bbe14946ca767ac89b9078a3c93

Brand Name

Quidel Triage® Total 5 Control 2

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Quidel Triage NT-proBNP Test is a fluorescence immunoassay to be usedwith the Quidel Triage Meter for the quantitative determination of N-terminal pro-Brain NatriureticPeptide (Quidel Triage® Total 5 Control 2) in EDTA anticoagulated whole blood and plasma specimens. The test is to beused as an aid in the diagnosis of individuals suspected of having congestive heart failure (Quidel Triage® Total 5 Control 2). The test is also to be used as an aid for the risk stratification ofpatients with heart failure and the risk stratification of patients with acute coronary syndromes(Quidel Triage® Total 5 Control 2). The test may also serve as an aid in the assessment of increased risk for cardiovascularevents and mortality in patients at risk for heart failure who have stable coronary artery disease

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