CK-MB, Myoglobin and Troponin I cardiac marker IVD, kit, fluorescent immunoassay
- UID
- IMP/IVD/2022/000064_3ce2d429515a978093d247ad60bb3df7_1238c8f795e7639a1f28b1d9066fcef9
- 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 Cardiac Panel is a fluorescence immunoassay to be used with the Quidel Triage Meters for the quantitative determination of creatine kinase MB (Quidel Triage® TOX Drug Screen, 94600 Control 2), myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (Quidel Triage® TOX Drug Screen, 94600 Control 2)
CK-MB, Myoglobin 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_3ce2d429515a978093d247ad60bb3df7_1238c8f795e7639a1f28b1d9066fcef9. 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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