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Pointe Phencyclidine (PCP) Reagent Set

HORIBA INSTRUMENTS INCORPORATED · Model 60-PH0020-100 · UDI-DI 00811727016454

LCM Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Pointe Phencyclidine (PCP) Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Phencyclidine (PCP) Reagent Set is intended for the qualitative and semi-quantitative determination of PCP in human urine at a cutoff value of 25 ng/mL. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.

Recalls

Date	Firm	Reason
2005-05-31	Applied Biotech Inc	The firm has discovered that a number of distributed devices of the Medplus ER Drug Screen Test may be incorrectly assembled which may give incorrect results. The product is an in

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.