Device Recall Captia Syphilis IgG

  • Modèle / numéro de série
    Product Code: 800-960, Lot number: 082, Model: 10 - plate kit
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA Nationwide Distribution in the state of WA
  • Description du dispositif
    Captia Syphilis-G Test Kit || Product Usage: This is an enzyme immunoassay for the qualitative detection of IgG antibodies to T. pallidum in serum specimens, to be used in conjunction with non-treponemal testing to provide serological evidence of infection with T. pallidum ( the agent of syphilis). It is also intended for testing of serum or plasma specimens to screen blood and/or plasma donors to exclude a history of syphilis.
  • 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