CDSCO UID IMP/IVD/2022/000064_e920296fa1e52bbb4411daca8cb851e8_cb239d14d79c1f9993ffb93de5e81d03
Troponin I 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_e920296fa1e52bbb4411daca8cb851e8_cb239d14d79c1f9993ffb93de5e81d03
- 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 TriageTrue High Sensitivity Troponin I Test is a fluorescence immunoassay to be used with the Triage® MeterPro for the quantitative determination of troponin I in EDTA anticoagulated whole blood and plasma specimens. The test is to be used as an aid in the diagnosis of myocardial infarction (Quidel Triage® TOX Drug Screen, 94600 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/2022/000064_e920296fa1e52bbb4411daca8cb851e8_cb239d14d79c1f9993ffb93de5e81d03. 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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