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Alere iScreen Dx

Instant Technologies, Inc. · Model IS10-22015-DX · UDI-DI 00817405020157

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1
510(k) clearances
5
Adverse events
1
Recalls
94
Facilities

Description

Urine Drug Screen Card for detection of 10 drugs, Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Ecstasy, Marijuana, Methadone, Methamphetamine, Morphine and Phencyclidine, CLIA Waived

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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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.