CDSCO UID IMP/IVD/2022/000064_607f5c611414c84d5d460dfba4c424da_93decaa2fc6160f7b4e63599bd018022
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, fluorescent immunoassay
Quidel Diagnostics India Pvt Ltd·Device Class Class C·India CDSCO·Brand: Quidel Triage® TOX Drug Screen, 94600 Control 2
Registration details
- UID
- IMP/IVD/2022/000064_607f5c611414c84d5d460dfba4c424da_93decaa2fc6160f7b4e63599bd018022
- Device class
- Class C
- Brand name
- Quidel Triage® TOX Drug Screen, 94600 Control 2
- License holder
- Quidel Diagnostics India Pvt Ltd
- 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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About this record
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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