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ToxCup Drug Screen Cup

AMEDITECH INC. · Model DT12A · UDI-DI 00816565020656

JXN LCM DJR DIS JXM DKZ DJC DJG DIO LDJ Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

THC50/COC150; OPI300/MET500; AMP500/BZO300; BAR300/MTD300; MDMA500/OXY100; PCP25/PPX300 with Cr, Ni, pH, Bl, S.G.

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.