Device Recall Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine

  • 모델명 / 제조번호(시리얼번호)
    Carton/Bottle Lot Number: S9093061A P9093061A  S9094081A P9094081A  S0097091C P0097091C  S9093061A P9093061A S9094081A P9094081A  S0097091C P0097091C  S0100101B P0100101B  S0103042A P0103042A  S0103042H P0103042H  S0106062A P0106062A  S9101022A P9101022A  S9101022B P9101022B  S9105052A P9105052A
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,
  • 제품 설명
    Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine || Chemistry || Catalog Number: 5019 || When used with the CLINITEK ATLAS¿ Automated urine Chemistry Analyzer and CLINITEK ATLAS¿ 10 reagent Pak, CLINITEK ATLAS¿ Positive and Negative Control Strips provide defined results for color, clarity, glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrite, and leukocytes. Each CLINITEK ATLAS Positive Control Strip is a firm plastic strip to which are affixed seven separate analyte areas.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Siemens Healthcare Diagnostics Inc, 2 Edgewater Dr, Norwood MA 02062-4637
  • 제조사 모회사 (2017)
  • Source
    USFDA