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/2022/000064_607f5c611414c84d5d460dfba4c424da_a1f883c56682d9cba833b6f61ae67982. This device is marketed under the brand name Quidel Triage® TOX Drug Screen, 94600 Control 2. The license holder is Quidel Diagnostics India Pvt Ltd, 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/2022/000064_607f5c611414c84d5d460dfba4c424da_a1f883c56682d9cba833b6f61ae67982

Brand Name

Quidel Triage® TOX Drug Screen, 94600 Control 2

License Holder

Quidel Diagnostics India Pvt Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

The Quidel Triage BNP Test is a rapid, point of care fluorescence immunoassay to be used with the Quidel Triage Meters for the quantitative measurement of B-type natriuretic peptide (Quidel Triage® TOX Drug Screen, 94600 Control 2) in EDTA anticoagulated whole blood or plasma specimens. The test is intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (Quidel Triage® TOX Drug Screen, 94600 Control 2). The test also is used for the risk stratification of patients with acute coronary syndromes and for the risk stratification of patients with heart failure

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B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, fluorescent immunoassay

Brand: Quidel Triage® Total 5 Control 2

M/s. Ortho Clinical Diagnostics India Private Limited

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

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

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