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Alere iCup Dx Pro

Instant Technologies, Inc. · Model I-DXP-1127-02 · UDI-DI 00817405020317

LCMLFGDJRDISNFTNFVNFYNGGNGLNFW Prescription
1
510(k) clearances
5
Adverse events
1
Recalls
95
Facilities

Description

Urine Drug Screening Device for detection of Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Ecstasy, Marijuana, Methamphetamine, Methadone, Opiate (300), Oxycodone, Phencyclidine and Tricyclic Antidepressants. CLIA Waived Test Cup

Recalls

DateFirmReason
2005-05-31Applied Biotech IncThe 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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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.