Device Recall AmediCheck Instant Test Cup

  • Modelo / Serial
    T0858
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide distribution in the states of: TN, NC, FL, and PA
  • Descripción del producto
    AmediCheck Instant Test Cup, Part No. C-C0501A-3A || Product Usage: || The AmediCheck Instant Test Cup is an in vitro diagnostic test for the rapid detection of the following drugs in human urine. Drug Analyte Cut off Device Code Marijuana THC 50 ng/mL THC Cocaine Benzoylecgonine 300 ng/mL COC Amphetamine Amphetamine 1000 ng/mL AMP Methamphetamine Methamphetamine 1000 ng/mL MET Opiates Morphine 2000 ng/mL OPI Opiates300 Morphine 300 ng/ml OPI300 Phencyclidine Phencyclidine 25 ng/mL PCP Barbiturates Secobarbital 300 ng/mL BAR Benzodiazepines Oxazepam 300 ng/mL BZD Methadone Methadone 300 ng/mL MTD Oxycodone Oxycodone 100 ng/mL OXY MDMA MDMA 500 ng/mL MDMA Tricyclic Antidepressants Nortriptyline 1000 ng/mL TCA
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Branan Medical Corporation, 140 Technology Dr Ste 400, Irvine CA 92618-2426
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA