Device Recall MONOLISA ANTIHBs EIA

  • Modèle / numéro de série
    All lots distributed from May 5, 2007
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Canada, South Africa, and Zimbabwe.
  • Description du dispositif
    The Bio-Rad MONOLISA Anti-HBs EIA is for In Vitro Diagnostic Use and it has the catalog number 25220. It is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. || The Bio-Rad MONOLISA Anti-HBs EIA is a qualitative and quantitative enzyme immunoassay for the detection of antibody for hepatitis B surface antigen in human serum and EDTA or citrated plasma. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Bio-Rad Laboratories, 6565 185th Ave NE, Redmond WA 98052-5039
  • Société-mère du fabricant (2017)
  • Source
    USFDA