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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_607f5c611414c84d5d460dfba4c424da_d676b932f3737cca1bd124cd65560e02. 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_607f5c611414c84d5d460dfba4c424da_d676b932f3737cca1bd124cd65560e02

Brand Name

Quidel Triage® Total 5 Control 2

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Quidel Triage BNP Test is a rapid, point of care fluorescence immunoassayto be used with the Quidel Triage Meters for the quantitative measurement of B-type natriureticpeptide (Quidel Triage® Total 5 Control 2) in EDTA anticoagulated whole blood or plasma specimens. The test is intended to beused as an aid in the diagnosis and assessment of severity of congestive heart failure (Quidel Triage® Total 5 Control 2). The test also is used for the risk stratification of patients with acute coronarysyndromes and for the risk stratification of patients with heart failure

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