FastPack Total PSA Immunoassay

  • Model / Serial
    Lot Numbers: 0807002-901, 0807002-903, 0807002-904, 0807002-905, 0807002-906, 0807002-907, 0807002-908, and 0807002-909.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution --- including USA and countries of Canada, UK , Italy, Switzerland, Sweden, & South Korea.
  • Product Description
    FastPack(R) Total PSA Immunoassay; Catalog #: 25000001 || 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(R) Total PSA immunoassay is designed for use with the FastPack (R) System.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Qualigen Inc, 2042 Corte del Nogal, Carlsbad CA 92011-1438
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    Total PSA: Catalog Number 25000040. Lot Number 1309038-10P Exp Date 6/26/2013.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.
  • Product Description
    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
  • Model / Serial
    25000001 | 0807002 (sublots -901, -903 through -909)
  • Product Description
    IVD: Prostate specific antigen kit
  • Manufacturer