FastPack Total PSA Immunoassay

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 0807002-901, 0807002-903, 0807002-904, 0807002-905, 0807002-906, 0807002-907, 0807002-908, and 0807002-909.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- including USA and countries of Canada, UK , Italy, Switzerland, Sweden, & South Korea.
  • 제품 설명
    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

제조사

  • 제조사 주소
    Qualigen Inc, 2042 Corte del Nogal, Carlsbad CA 92011-1438
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Total PSA: Catalog Number 25000040. Lot Number 1309038-10P Exp Date 6/26/2013.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.
  • 제품 설명
    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
  • 모델명 / 제조번호(시리얼번호)
    25000001 | 0807002 (sublots -901, -903 through -909)
  • 제품 설명
    IVD: Prostate specific antigen kit
  • Manufacturer