Drugs of Abuse Control Levels - India CDSCO Medical Device Registration

Drugs of Abuse Control Levels is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000187_9e05fd006a557fb5f1fa96c2ba9c12bb_c0447c1926f9eb605805b5cebda7e9f9. This device is marketed under the brand name VITROS Chemistry Products AMPH Reagent. 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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CDSCO Registered

Class Class C

Drugs of Abuse Control Levels

UID: IMP/MD/2018/000187_9e05fd006a557fb5f1fa96c2ba9c12bb_c0447c1926f9eb605805b5cebda7e9f9

Brand Name

VITROS Chemistry Products AMPH Reagent

License Holder

M/s. Ortho Clinical Diagnostics India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

For in vitro diagnostic use only. VITROS Chemistry Products DAT Performance Verifiers are assayed controls used to monitor performance of urine drugs of abuse screening assays on the VITROS Chemistry System and VITROS Integrated System

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