Devices

Device Recall Legionella IFA Substrate Slide

  • Modèle / numéro de série
    IF0951: 10816101020055, lot numbers 29428, 31871
  • Classification du dispositif
    Immunology and Microbiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product was distributed to three testing laboratories in California, New Jersey and Virginia
  • Description du dispositif
    Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
  • Manufacturer
    Focus Diagnostics Inc
  • 1 Event

Fabricant

Focus Diagnostics Inc
  • Adresse du fabricant
    Focus Diagnostics Inc, 11331 Valley View St, Cypress CA 90630-5366
  • Source
    USFDA