Cocaine metabolite Reagent - India CDSCO Medical Device Registration

Cocaine metabolite Reagent is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000187_c8fbc7fa0b2fe6edbc4a7f97b44debb6_48adb935b90052e1fc8e660799c0b553. 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

Cocaine metabolite Reagent

UID: IMP/MD/2018/000187_c8fbc7fa0b2fe6edbc4a7f97b44debb6_48adb935b90052e1fc8e660799c0b553

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 COCM Reagent is used on the VITROS Chemistry System and VITROS Integrated System for the semi-quantitative or qualitative determination of benzoylecgonine (VITROS Chemistry Products AMPH Reagent) in human urine using a cutoff of either 150 ng/mL or 300 ng/mL. Measurements obtained with the VITROS COCM method are used in the diagnosis and treatment of cocaine use or overdose

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