Device Recall Xpert MRSA

  • 모델명 / 제조번호(시리얼번호)
    Catalog number: GXMRSA-120, Rev. AJ; Lot numbers: 1000037539 (Cartridge lot 20417) and 1000029307 (Cartridge lot 20419).
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US only: PA, DE, FL, SC, ME, CA, IL, NC, TX, WA, NY, TN, FL, OR, OK, MO, MS, GA, NM, IN, OH, MD, VA, CO, AZ, and NC.
  • 제품 설명
    Xpert MRSA || Catalog GXMRSA-120, Rev. AJ || Microbiology: || The Cepheid Xpert MRSA assay performed in the GeneXpert Dx System || (Xpert MRSA) is a qualitative in vitro diagnostic test designed for rapid detection of Methicillin-Resistant Staphylococcus Aureus (MRSA) from nasal swabs in patients at risk for nasal colonization
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Cepheid, 904 E Caribbean Dr, Sunnyvale CA 94089-1189
  • 제조사 모회사 (2017)
  • Source
    USFDA