Device Recall Spectrolyse PAI1

  • Modèle / numéro de série
    Lot Numbers: 120425 and 120601
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: USA including states of: FL, IN, IL, and WA.
  • Description du dispositif
    Sekisui Spectrolyse PAI-1, In-Vitro Diagnostic for Quantitative determination of Plasminogen Activator Inhibitor Type- 1 (PAI-1) activity in human plasma. || Catalog Number: 101201 || For the determination of Plasminogen Activator Inhibitor Type 1 (PAI-1) activity in human plasma. The test is for in Citro diagnostic use.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Sekisui Diagnostics Llc, 500 West Avenue, Stamford CT 06902
  • Société-mère du fabricant (2017)
  • Source
    USFDA