Device Recall Streptex Latex D, Ref R30950901 ZL54

  • Modèle / numéro de série
    Lot 1149576, exp January 2014
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. || Streptex is a rapid latex test system for use in the qualitative detection and identification of the Lancefield group of streptococci
  • 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