Cobas

  • 모델명 / 제조번호(시리얼번호)
    Lot #s: 70712A (6 kits); 70601W (76 kits); 70713A (4 kits); 70718A (50 kits); and 70809A (kits were not distributed to end users).
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution. Austria, Denmark, Germany, Singapore, Netherlands, Hong Kong, and Switzerland. US product is not affected.
  • 제품 설명
    Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Roche Molecular Systems, Inc., 1080 US Highway 202 S, Branchburg NJ 08876-3733
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 918 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Laboratory reagents requiring manual handling for use in combination with cobas c 502 analyser made by Hitachi, supplied by Roche. Multiple tests are affected, including syphilis (TPLA) test made by Sekisui. All reagents are supplied by Roche. The analyser can run assays that are: manufactured by Roche manufactured by third parties and supplied by Roche – ‘partnership assays’ (eg TPLA) Affected assays include those requiring manual handling that are listed in the Roche Field Safety Notice
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Hitachi High Technologies: Cobas 6000, Cobas 8000
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Hitachi: Cobas 8000 core unit
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Hitachi: cobas 8000 modular analyzer cobas e801 module
  • Manufacturer
하나 더 913 건 더