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CDSCO UID IMP/MD/2018/000187_c8fbc7fa0b2fe6edbc4a7f97b44debb6_48adb935b90052e1fc8e660799c0b553

Cocaine metabolite Reagent

M/s. Ortho Clinical Diagnostics India Private LimitedDevice Class Class CIndia CDSCOBrand: VITROS Chemistry Products AMPH Reagent
VerifiedCDSCO · official registry
Registration details
UID
IMP/MD/2018/000187_c8fbc7fa0b2fe6edbc4a7f97b44debb6_48adb935b90052e1fc8e660799c0b553
Device class
Class C
Brand name
VITROS Chemistry Products AMPH Reagent
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
About this record

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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