Devices

Device Recall Legionella IFA Substrate Slide

  • 모델명 / 제조번호(시리얼번호)
    IF0951: 10816101020055, lot numbers 29428, 31871
  • 의료기기 분류등급
    Immunology and Microbiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was distributed to three testing laboratories in California, New Jersey and Virginia
  • 제품 설명
    Legionella IFA Substrate Slide (IF0951) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
  • Manufacturer
    Focus Diagnostics Inc
  • 1 Event

제조사

Focus Diagnostics Inc
  • 제조사 주소
    Focus Diagnostics Inc, 11331 Valley View St, Cypress CA 90630-5366
  • Source
    USFDA