Device Recall Dimension Vista LOCI Estradiol Test

  • Modèle / numéro de série
    All lots
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution  US Nationwide , AR, AU, AU, BD, BO, BR, CA, CH, CL, CN, CO, DO, EC, EG, HK, ID, IE, IL, IN, JP, KR, LK, LY, MX, MY, NI, NP, NZ, PE, PH, PY, SA, SG, SV, TH, TW, UY, VE, VN, and ZA.
  • Description du dispositif
    Dimension Vista LOCI Estradiol || Test Code E2 || Catalog Number: K6463 || SMN: 10489099 || Product Usage: || The E2 method is an in vitro diagnostic test for the quantitative measurement of estradiol in human serum and plasma on the Dimension Vista¿System. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Siemens Healthcare Diagnostics, Inc, 333 Coney St, East Walpole MA 02032-1516
  • Société-mère du fabricant (2017)
  • Source
    USFDA