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Multiple drugs of abuse IVD, kit, fluorescent immunoassay - India CDSCO Medical Device Registration

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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered
Class Class C
Multiple drugs of abuse IVD, kit, fluorescent immunoassay
UID: IMP/IVD/2023/000472_3c6e5471a1e34c2bf67db73af89fb72f_a24b75be18cc778f3f9ec7cae184b4ab

Brand Name

Quidel Triage® Total 5 Control 2

Device Class

Class C

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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