Device Recall Sex Hormone Binding Blobulin (SHBG) Reagent

  • Modèle / numéro de série
    Lot Numbers:009046, 010202, 829586, 909837, 914557, 915628,  917613, 919184
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AL, AR, CA, CO, FL, GA, IL, IN, LA, MA, MI, MN, MO, MS, NC, NE, NV, NY, OH, OK, OR, TN, TX, UT, VA, WA, AND WI and the country of Canada
  • Description du dispositif
    Sex Hormone Binding Globulin (SHBG) Reagent for use on Access Immunoassay Systems, Part number(s): A48617 || The Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Beckman Coulter Inc., 200 S Kraemer Blvd, Brea CA 92821-6208
  • Société-mère du fabricant (2017)
  • Source
    USFDA