Device Recall Rubella IgG EIA test kit

  • Modèle / numéro de série
    Lot F1108
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: NE, NY, FL, GA, MA, OR, WI, MN, MI, MS, NC, CA, MD, MO, IA, DC
  • Description du dispositif
    Rubella IgG EIA test kit, containing 1 Rubella IgG Microplate, 1 Negative Control, 1 High Positive Control, 1 Low Positive Control, 1 Substrate, 1 Stop Reagent. Labeled: Distributed by: Bio-Rad Laboratories-Redmond, WA 98052 || For the qualitative, semi-quantitative and quantitative detection of human IgG antibodies to rubella virus in human serum by enzyme immunoassay, to aid in the assessment to the patient's immunological response to rubella, and as a qualitative screening test to determine the immune status of individuals, including women of childbearing age.
  • 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