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Rapid Response

BTNX Inc · Model D12.5-1T · UDI-DI 00722066003695

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510(k) clearances

Adverse events

Recalls

Facilities

Description

Rapid Response Multi Drug One Step Cup (AMP/BAR/BUP/BZO/COC/MDMA/MTD/MET/OPI/OXY/THC/PCP) - 25 Tests/ kit are for the qualitative detection of Amphetamine, Barbiturate, Buprenorphine, Bezodiazepines, 3,4-Methylenedioxy-Methamphetamine, Methamphetamine, Methadone, Opiates, Oxycodone, Phencyclidine, Cocaine and THC metabolites in urine.

Recalls

Date	Firm	Reason
2005-05-31	Applied Biotech Inc	The 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.