bioMerieux Inc

데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 5 건

  • 모델명 / 제조번호(시리얼번호)
    Lot #P108X
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution was nationwide to medical facilities and laboratories. Foreign distribution was made to China and Switzerland.
  • 제품 설명
    VITEK GPS-107 Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC.
  • 모델명 / 제조번호(시리얼번호)
    Lot #B28E
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution was made to medical centers and laboratories nationwide, which include government and military consignees. Foreign distribution was made to bioMerieux subsidiaries in Switzerland, Portugal, and the Philippines.
  • 제품 설명
    VITEK GPS-107Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC.
  • 모델명 / 제조번호(시리얼번호)
    Software version R.02.00.17
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    WorldwideDistribution--Nationwide to medical centers. Government distribution was made to MN and CA, and military distribution was made to OK. Foreign distribution was made to Thailand, The Netherlands, Germany, Greece, Portugal, and France.
  • 제품 설명
    OBSERVA R02 (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners which are connected to BacT/ALERT 3D
  • 모델명 / 제조번호(시리얼번호)
    Lot #M83X, Exp. 4/15/05
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution was made nationwide to medical facilities, which includes military and government consignees. Distribution was also made to foreign consignees located in Colombia, Costa Rica, and China.
  • 제품 설명
    VITEK GPS-107Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC.
  • 모델명 / 제조번호(시리얼번호)
    Lot P61X, Exp. 5/12/05
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distribution was nationwide to medical facilities, including V.A. and military customers. There was no foreign distribution.
  • 제품 설명
    VITEK GPS-106 Gram Positive Susceptibility Card, Catalog #V4335, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC and bioMerieux sa, France.

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 23 건

데이터에 대해 더 자세히 알아보기 여기

  • 제조사 주소
    Biomerieux Inc, 595 Anglum Rd, Hazelwood MO 63042-2320
  • 제조사 모회사 (2017)
  • Source
    USFDA
하나 더 18 건 더