Device Recall Nanosphere Verigene CYP2C19 Nucleic Acid Test

  • Modelo / Serial
    (Catalog No. 20-005-019)    Kit Numbers (US Distribution): 051013019-9, 6288-1, 6547-1, 6420-1, 5478-1, 5802-1, 6190-1, 7360-3, 5452-2, 6499-1, 6414-1, 7183-1, 7511-1, 5225-1, 5225-2, 6495-1, 5760-1, 5779-1, 7259-1, 6783-1, 7435-1    Kit Numbers (Foreign Distribution): 7300-4, 5500-1, 5908-3, 5970-3, 6402-1, 6402-2, 6105-1, 6123-1, 6793-1, 6827-1, 6224-1
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including the states of AL, CA, MD, ND, NJ, OK and TX., and internationally to Bulgaria, China and New Zealand.
  • Descripción del producto
    Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic Acid Test Cartridges and 20 Verigene CYP2C19 Nucleic Acid Extraction Trays (with Tip Holder Assemblies). Clinical laboratory test.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Nanosphere, Inc., 4088 Commercial Ave, Northbrook IL 60062-1829
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA