Devices

Device Recall PLAC Test Reagent Kit

  • Modèle / numéro de série
    All lot codes under recall.
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US, OUS: UK and Germany.
  • Description du dispositif
    PLAC Test Reagent Kit, Catalog numbers 90107 and 90110, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in human plasma or serum. Product consists of a liquid, ready to use, two reagent kit assembled in a kit box.
  • Manufacturer
    DiaDexus, Inc
  • 1 Event

Fabricant

DiaDexus, Inc
  • Adresse du fabricant
    DiaDexus, Inc, 343 Oyster Point Blvd, South San Francisco CA 94080-1913
  • Société-mère du fabricant (2017)
    DiaDexus, Inc
  • Source
    USFDA