Rapid Response
BTNX Inc · Model D12.8-1P29-25 · UDI-DI 00722066003671
1
510(k) clearances
5
Adverse events
1
Recalls
95
Facilities
Description
Rapid Response Multi Drug Test Panels (COC/AMP/MET/THC/MTD/MDMA/OPI/OXY/PPX/PCP/BZO/BAR) - 25 tests/ kit are for the qualitative detection of Amphetamine, Methamphetamine, Methadone, 3,4-Methylenedioxy-Methamphetamine, Opiates, Oxycodone, Propoxyphene, Phencyclidine, Benzodiazepines, Barbiturate, 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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Get your free API keyRead the docsData 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.