Device Recall Captia VZV IgG

  • Modèle / numéro de série
    Kit lot codes: 2325600-566, 2325601-566, 2325600-567, 2325601-567, 2325600-568
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution-including Puerto Rico and the states of AL, CA, IL, IN, MA, MD, NJ, OH, PA, TN, TX.
  • Description du dispositif
    Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. || For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Clark Laboratories, Inc. (dba,Trinity Biotech USA), 2823 Girts Road, Jamestown NY 14701
  • Société-mère du fabricant (2017)
  • Source
    USFDA