Devices

Device Recall EliA

  • Modelo / Serial
    Product number: 14-5624-01 Lot: 0018 Exp date: 11/30/2016
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide in the states of NC, GA, NJ, NY, PA, TX, IL, MI, MT, NM, and OR.
  • Descripción del producto
    EliA SmDP Well, Article Number 14-5624-01 || Product Usage: || EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instruments Phadia 100 and Phadia 250.
  • Manufacturer
    Phadia Ab
  • 1 Event

Fabricante

Phadia Ab
  • Dirección del fabricante
    Phadia Ab, Rapsgatan 7, Rapsgatan Plant, Uppsala Sweden
  • Empresa matriz del fabricante (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA

Dispositivo con un nombre similar

Más información acerca de la data acá

Device Recall EliA Sample Diluent, Article number, 83102301
  • Modelo / Serial
    EliA Sample Diluent, Article number, 83-1023-01, lots JM3Y, JS0B, JP87, JK5N, and JU9C
  • Clasificación del producto
    Immunology and Microbiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Domestic: AR, CA, CO, FL, GA, IL, IN, KY, LA, MI, MN, MO, MT, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, WI, WV Foreign: None VA/DOD: None
  • Descripción del producto
    EliA Sample Diluent, Article number, 83-1023-01
  • Manufacturer
    Phadia US Inc