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/2022/000064_3c6e5471a1e34c2bf67db73af89fb72f_2d10d7bf2c8fab0584dd6bc4283766ad. 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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CDSCO Registered

Class Class C

Multiple drugs of abuse IVD, kit, fluorescent immunoassay

UID: IMP/IVD/2022/000064_3c6e5471a1e34c2bf67db73af89fb72f_2d10d7bf2c8fab0584dd6bc4283766ad

Brand Name

Quidel Triage® TOX Drug Screen, 94600 Control 2

License Holder

Quidel Diagnostics India Pvt Ltd

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® TOX Drug Screen, 94600 Control 2), Liquid Chromatography / Mass Spectroscopy / Mass Spectroscopy (Quidel Triage® TOX Drug Screen, 94600 Control 2) and High Performance Liquid Chromatography (Quidel Triage® TOX Drug Screen, 94600 Control 2) are common confirmatory methods.

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Multiple drugs of abuse IVD, kit, fluorescent immunoassay

Brand: Quidel Triage® Total 5 Control 2

M/s. Ortho Clinical Diagnostics India Private Limited

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

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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Multiple drugs of abuse IVD, kit, fluorescent immunoassay

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