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PROFILE-II ER®

MEDTOX DIAGNOSTICS, INC. · Model 601636 · UDI-DI 00690286000285

JXN DIS DJR LFG JXM DKZ DJG DJC DIO DKE Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

A qualitative one-step immunochromatographic test panel for the detection of Cannabinoids (THC), Opiates, Amphetamines, Cocaine, Tricyclic Antidepressants, Barbiturates, Methadone, Benzodiazepines, Propoxyphene (PPX), Methamphetamine (MAMP), 3,4-Methylenedioxymethamphetamine (MDMA) drugs and/or metabolites in human urine.

Recalls

Date	Firm	Reason
2010-10-04	Express Diagnostics Int'l., Inc.	Express Diagnostics Int'l, Inc (EDI), is recalling DrugCheck Drug Screen Cups containing buprenorphine (BUP) and propoxyphene (PPX) because they must be labeled as "forensic use o
2008-05-28	Sun Biomedical Laboratories, Inc.	Product was sold while the devices were under FDA 510 (k) review, which was subsequently denied.

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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.