CDSCO UID IMP/IVD/2023/000472_607f5c611414c84d5d460dfba4c424da_d676b932f3737cca1bd124cd65560e02
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, fluorescent immunoassay
M/s. Ortho Clinical Diagnostics India Private Limited·Device Class Class C·India CDSCO·Brand: Quidel Triage® Total 5 Control 2
Registration details
- UID
- IMP/IVD/2023/000472_607f5c611414c84d5d460dfba4c424da_d676b932f3737cca1bd124cd65560e02
- Device class
- Class C
- Brand name
- Quidel Triage® Total 5 Control 2
- License holder
- M/s. Ortho Clinical Diagnostics India Private Limited
- 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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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/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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