Phencyclidine Reagent - India CDSCO Medical Device Registration

Phencyclidine Reagent is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000187_b4deb3e43e3ec00c51e281a2166825f3_b6c9a52b315dfac6052d3305ece7b8b3. 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

Phencyclidine Reagent

UID: IMP/MD/2018/000187_b4deb3e43e3ec00c51e281a2166825f3_b6c9a52b315dfac6052d3305ece7b8b3

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 PCP Reagent is used on the VITROS Chemistry System and VITROS Integrated System for the semi-quantitative or qualitative determination of phencyclidine (VITROS Chemistry Products AMPH Reagent) in human urine using a cutoff of 25 ng/mL. Measurements obtained with the VITROS PCP method are used in the diagnosis and treatment of phencyclidine use or overdose

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