Device Recall FastPack Testosterone Immunoassay

  • Model / Serial
    Testosterone. Catalog Number 25000041. Lot Number 1310019-3P Exp Date: 9/22/2014
  • Product Classification
  • Device Class
    1
  • 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 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

Manufacturer

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