Device Recall Staphytect Plus

  • 모델명 / 제조번호(시리얼번호)
    100-test boxes - Lot Numbers: J539110, Exp. Nov 2009, and J591710, Exp. Jan 2010;  500-test boxes - Lot Numbers: J577920, Exp. Jan 2010; and J610620, Exp. May 2010
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution -- MN, CT, FL, GA, CA, NY, MI, MO, PA, and IL.
  • 제품 설명
    Staphytect Plus, packaged in 100- and 500-test boxes, Catalog #DR0850M (100 tests) and #DR0850B (500 tests). Oxoid Ltd., Wade Road, Basingstoke, Hants UK. || Latex slide agglutination test for the differentiation of staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccarides found in methicillin-resistant S. aureus (MRSA) from those staphylococci that do not possess these properties.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Remel, Inc, 12076 Santa Fe Trail Dr, Lenexa KS 66215-3519
  • Source
    USFDA