Barbiturates Reagent - India CDSCO Medical Device Registration

Barbiturates Reagent is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000187_f15c017bd4055d75b65b106d92e39d68_8dc9d78582df013837d4b5c0ee55f429. 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

Barbiturates Reagent

UID: IMP/MD/2018/000187_f15c017bd4055d75b65b106d92e39d68_8dc9d78582df013837d4b5c0ee55f429

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

VITROS Chemistry Products BARB Reagent is used on the VITROS Chemistry System and the VITROS Integrated System for the semi-quantitative or qualitative determination of barbiturates (VITROS Chemistry Products AMPH Reagent) in human urine using a cutoff of either 200 ng/mL or 300 ng/mL. Measurements obtained with the VITROS BARB assay are used in the diagnosis and treatment of barbiturates use or overdose

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