Device Recall PathoDx Strep B Grouping Latex

  • Modèle / numéro de série
    lot 1463129, exp. date 31 May 2016
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution, including Puerto Rico and the country of Canada.
  • Description du dispositif
    PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap. || Latex reagent for streptococcal group B; Identify beta-hemolytic streptococci of Lancefield Groups A, B, C, F and G from primary culture plates.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Remel Inc, 12076 Santa Fe Trail Dr, Lenexa KS 66215-3519
  • Société-mère du fabricant (2017)
  • Source
    USFDA