CDSCO UID IMP/MD/2018/000187_b4deb3e43e3ec00c51e281a2166825f3_b6c9a52b315dfac6052d3305ece7b8b3

Phencyclidine Reagent

M/s. Ortho Clinical Diagnostics India Private Limited·Device Class Class C·India CDSCO·Brand: VITROS Chemistry Products AMPH Reagent
Registration details
UID
IMP/MD/2018/000187_b4deb3e43e3ec00c51e281a2166825f3_b6c9a52b315dfac6052d3305ece7b8b3
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 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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About this record

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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