CDSCO UID IMP/IVD/2023/000472_e920296fa1e52bbb4411daca8cb851e8_0a1ac4418eff6fda31d130f82350cc52
Troponin I 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_e920296fa1e52bbb4411daca8cb851e8_0a1ac4418eff6fda31d130f82350cc52
- 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 TriageTrue High Sensitivity Troponin I Test is a fluorescenceimmunoassay to be used with the Triage® MeterPro for the quantitative determination of troponinI in EDTA anticoagulated whole blood and plasma specimens. The test is to be used as an aid in thediagnosis of myocardial infarction (Quidel Triage® Total 5 Control 2)
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About this record
Troponin I IVD, kit, fluorescent immunoassay is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000472_e920296fa1e52bbb4411daca8cb851e8_0a1ac4418eff6fda31d130f82350cc52. 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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