Devices

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
    Immunology and Microbiology Devices
  • 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
    Roche Molecular Systems, Inc.
  • 1 Event

제조사

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

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

데이터에 대해 더 자세히 알아보기 여기

COBAS 8100 BRF SYSTEM
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: MODULE BRF SW (Lot serial: Version 02-XX)
  • 제품 설명
    COBAS 8100 BRF SYSTEM
  • Manufacturer
    ROCHE DIAGNOSTICS
COBAS TAQMAN HBV TEST
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 03500756190 (Lot serial: all lots); Model Catalog: 03543005190 (Lot serial: all lots); Model Catalog: 03502341190 (Lot serial: all lots); Model Catalog: 03587819190 (Lot serial: all lots); Model Catalog: 03568547190 (Lot serial: all lots)
  • 제품 설명
    COBAS TAQMAN HBV TEST
  • Manufacturer
    ROCHE DIAGNOSTICS
COBAS P512 PRE-ANALYTICAL SYSTEM
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 05083435001 (Lot serial: S/N: 4728845)
  • 제품 설명
    P512 PRE-ANALYTICAL SYSTEM
  • Manufacturer
    ROCHE DIAGNOSTICS
COBAS 4000 - COBAS C 311 (STAND ALONE CONFIGURATION)
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 04826876001 (Lot serial: ALL SOFTWARE VERSIONS)
  • 제품 설명
    Cobas 4000 - Cobas C311 (stand alone configuration)
  • Manufacturer
    ROCHE DIAGNOSTICS
VANC2 (ONLINE TDM VANCOMYCIN FOR ROCHE/HITACHI COBAS C 311 AND C 501/502 SYSTEMS
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 04491050190 (Lot serial: NA)
  • 제품 설명
    ONLINE TDM VANCOMYCIN FOR ROCHE/HITACHI COBAS C
  • Manufacturer
    ROCHE DIAGNOSTICS
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