Device Recall FastPack Vitamin D Immunoassay

  • 모델명 / 제조번호(시리얼번호)
    Testosterone. Catalog Number 25000059. Lot Number 1309062-2P.Exp Date: 7/9/2014
  • 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 Free T4 Immunoassay || FastPack Vitamin D Immunoassay || Chemilunescence assay for the determination of Vitamin D || The FastPack Vitamin D Immunoassay is intended for the quantitative determination of 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.
  • Manufacturer
  • 1 Event

제조사

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