Device Recall DSL108000 Active IPTH ELISA

  • Modèle / numéro de série
    Lot Numbers: 891198, 990980, 991448
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including the states of CA, CT, IA, IL, MI, NY, SC, and TX
  • Description du dispositif
    Active I-PTH Enzyme-Linked Immunosorbent Assay(ELISA), Part Number: DSL-10-8000 || The DSL-10-8000 ACTIVE I-PTH Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of I-PTH in serum or plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis of hyperparathyroidism
  • 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