CDSCO UID IMP/IVD/2022/000064_466a3ec8cf5319b46685dc3f7eb9e682_3d64f5c3d150cd0e71f1ae021be60f6b
BNP, CK-MB and Troponin I cardiac marker 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_466a3ec8cf5319b46685dc3f7eb9e682_3d64f5c3d150cd0e71f1ae021be60f6b
- 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 Cardio3 Panel is a fluorescence immunoassay to be used with the Quidel Triage Meters for the rapid quantitative determination of creatine kinase MB, troponin I, and B-type natriuretic peptide in EDTA anticoagulated whole blood and plasma specimens. The Quidel Triage Cardio3 Panel is to be used as an aid in the diagnosis of myocardial infarction (Quidel Triage® TOX Drug Screen, 94600 Control 2), an aid in the diagnosis and assessment of severity of congestive heart failure (Quidel Triage® TOX Drug Screen, 94600 Control 2), an aid in the risk stratification of patients with heart failure, and an aid in the risk stratification of patients with acute coronary syndromes
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About this record
BNP, CK-MB and Troponin I cardiac marker IVD, kit, fluorescent immunoassay is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000064_466a3ec8cf5319b46685dc3f7eb9e682_3d64f5c3d150cd0e71f1ae021be60f6b. 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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