Device Recall FastPack Testosterone Immunoassay

  • 모델명 / 제조번호(시리얼번호)
    Testosterone. Catalog Number 25000041. Lot Number 1310019-3P Exp Date: 9/22/2014
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 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 Testosterone Immunoassay || Chemilunescence assay for the determination of Testosterone || The FastPack Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended strictly for in-vitro diagnostic use as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. The FastPack Testo Immunoassay is designed for use with the FastPack System.
  • Manufacturer
  • 1 Event

제조사

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