Device Recall FastPack Free T4 Immunoassay

  • Modèle / numéro de série
    Testosterone. Catalog Number 25000043. Lot Number 1310028-2P.Exp Date: 4/10/2014
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to states of: AL, CA, KS, KY, IN, MA, NC, NY, NV, OK, SC, TN, TX, UT, VA, and WA.
  • Description du dispositif
    FastPack Free T4 Immunoassay || Chemilunescence assay for the determination of Free T4 || The FastPack free T4 Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of FT4 in human serum. The FastPack free T4 Immunoassay is designed for use with the FastPack System.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Qualigen Inc, 2042 Corte del Nogal, Carlsbad CA 92011-1438
  • Société-mère du fabricant (2017)
  • Source
    USFDA