CDSCO UID IMP/IVD/2020/000077_afab7778696a60cf9107648f8548d9f2_f9b03850a9d0996270e888f5e4d39c5f
Multiple cardiac marker IVD, kit, fluorescent immunoassay
M/s Parekh Integrated Services Pvt. Ltd.·Device Class Class C·India CDSCO·Brand: Quidel Triage® Total 3 Control 1
Registration details
- UID
- IMP/IVD/2020/000077_afab7778696a60cf9107648f8548d9f2_f9b03850a9d0996270e888f5e4d39c5f
- Device class
- Class C
- Brand name
- Quidel Triage® Total 3 Control 1
- License holder
- M/s Parekh Integrated Services Pvt. Ltd.
- Approving authority
- CDSCO
- Product information
- The Quidel Triage Profiler SOB (Quidel Triage® Total 3 Control 1) 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® Total 3 Control 1), 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
Multiple cardiac marker IVD, kit, fluorescent immunoassay is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000077_afab7778696a60cf9107648f8548d9f2_f9b03850a9d0996270e888f5e4d39c5f. This device is marketed under the brand name Quidel Triage® Total 3 Control 1. The license holder is M/s Parekh Integrated Services Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.
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