Device Recall Staphaurex Plus Kit

  • 모델명 / 제조번호(시리얼번호)
    Lot No. J311510, Expiry Date 2009.04.30, and Lot J477610, Expiry Date 2009.10.31;  Lot No. J311610, Expiry Date 2009.04.30; Lot No. J477710, Expiry Date 2009.10.31; and J359510, Expiry Date 2009.07.31
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA and Canada.
  • 제품 설명
    Remel Staphaurex Plus Kit, Catalog No. R30950102 (150 tests) and Catalog No. R30950201 (450 tests), rapid latex agglutination test for the identification of Staphylococcus aureus The responsible firm listed as Remel Europe Ltd, Dartford, England.
  • Manufacturer
  • 1 Event

제조사

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