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ImmuTest Drugs of Abuse Cup

AMEDITECH INC. · Model IMCA-11OP · UDI-DI 00816565020311

JXNDJRDKZLCMDJGDJCLDJDIODISJXM Prescription
1
510(k) clearances
1
Adverse events
2
Recalls
55
Facilities

Description

11 panel test cup, (BZO/BAR)+(COC/THC)+(MET/OPI)+(PCP/AMP)+MTD+OXY+PPX with Cr, Ni, pH, Bl, S.G. adulteration tests

Recalls

DateFirmReason
2010-10-04Express 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
2008-05-28Sun 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.