Device Recall FastPack Total PSA Immunoassay

  • Modèle / numéro de série
    Total PSA: Catalog Number 25000040. Lot Number 1309038-10P Exp Date 6/26/2013.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.
  • Description du dispositif
    FastPack Total PSA Immunoassay || Chemilunescence assay for the determination of Total PSA. || FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid in the management of patients with prostate cancer. The FastPack Total PSA Immunoassay is designed for use with the FastPack System.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Qualigen Inc, 2042 Corte del Nogal, Carlsbad CA 92011-1438
  • Société-mère du fabricant (2017)
  • Source
    USFDA