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_93decaa2fc6160f7b4e63599bd018022. 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_93decaa2fc6160f7b4e63599bd018022

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 NT-proBNP Test is a fluorescence immunoassay to be used with the Quidel Triage Meter for the quantitative determination of N-terminal pro-Brain Natriuretic Peptide (Quidel Triage® TOX Drug Screen, 94600 Control 2) in EDTA anticoagulated whole blood and plasma specimens. The test is to be used as an aid in the diagnosis of individuals suspected of having congestive heart failure (Quidel Triage® TOX Drug Screen, 94600 Control 2). The test is also to be used as an aid for the risk stratification of patients with heart failure and the risk stratification of patients with acute coronary syndromes (Quidel Triage® TOX Drug Screen, 94600 Control 2). The test may also serve as an aid in the assessment of increased risk for cardiovascular events and mortality in patients at risk for heart failure who have stable coronary artery disease

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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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