CDSCO UID IMP/IVD/2023/000472_3c6e5471a1e34c2bf67db73af89fb72f_a24b75be18cc778f3f9ec7cae184b4ab
Multiple drugs of abuse 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_3c6e5471a1e34c2bf67db73af89fb72f_a24b75be18cc778f3f9ec7cae184b4ab
- 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 Triage TOX Drug Screen, 94600 is a fluorescence immunoassay to be used with the Quidel Triage MeterPro for the qualitative determination of the presence of drugs and/or metabolites in human urine of up to 9 drug assays at or above the threshold concentrations. This test provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Gas Chromatography / Mass Spectroscopy (Quidel Triage® Total 5 Control 2), Liquid Chromatography / Mass Spectroscopy / Mass Spectroscopy (Quidel Triage® Total 5 Control 2) and High Performance Liquid Chromatography (Quidel Triage® Total 5 Control 2) are common confirmatory methods
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About this record
Multiple drugs of abuse IVD, kit, fluorescent immunoassay is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000472_3c6e5471a1e34c2bf67db73af89fb72f_a24b75be18cc778f3f9ec7cae184b4ab. 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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