CDSCO UID IMP/IVD/2022/000064_71d7d92cf610af22477d63392fae35e0_8fe3a7d855ebdd000cb073fb592e0f16
Troponin I, BNP and D-dimer 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_71d7d92cf610af22477d63392fae35e0_8fe3a7d855ebdd000cb073fb592e0f16
- 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 Profiler SOB (Quidel Triage® TOX Drug Screen, 94600 Control 2) Panel is a fluorescence immunoassay to be used with the Quidel Triage Meters for the quantitative determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens. The test is 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 heart failure, an aid in the risk stratification of patients with heart failure, an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism and an aid in the risk stratification of patients with acute coronary syndromes
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About this record
Troponin I, BNP and D-dimer 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_71d7d92cf610af22477d63392fae35e0_8fe3a7d855ebdd000cb073fb592e0f16. 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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