Device Recall mini VIDAS

  • 모델명 / 제조번호(시리얼번호)
    Description, Reference No. (UDI No.): MINI VIDAS ANALYSER EU, 99174 (03573026111021); MINI VIDAS ANALYSER US, 99175 (03573026111045); MINI VIDAS 100-120 VOLT VDE/CE, 99733 (03573026118662); MINI VIDAS 200-240 VOLT VDE/CE, 99734 (03573026118655); MINI VIDAS BLUE 110 / 220 V, 99737 (03573026140441); MINI VIDAS ARKRAY ANALYZER, 99739 (03573026140465); MINI VIDAS, 410416 (03573026351656); MINI VIDAS, W1421 (03573026029180); MINIVIDAS INDUSTRY US, 421001 (03573026553319)
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, VT, WA, WI, WV, WY. International distribution to Algeria, Angola, Anguilla, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bolivia, Bosnia - Herzegovina, Brazil, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroon, Canada, Cape Verde, Chad, Chile, China / Hong Kong, Colombia, Congo, Costa Rica, Croatia, Czech Republic, Denmark, Djibouti, Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guam, Guatemala, Guinea, Honduras, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Ivory Coast, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mali, Malta, Mauretania, Mexico, Mongolia, Morocco, Mozambique, Myanmar, Nepal, Netherlands, Nicaragua, Niger, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Senegal, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Tanzania, Thailand, Togo, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietnam, Zimbabwe.
  • 제품 설명
    BioMerieux mini VIDAS System in combination with Quality Control VIDAS* (QCV*) || Product Usage: || the Quality Control VIDAS (QCV) is an automated test for use on the VIDAS¿ system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical systems. Specifically the mini VIDAS system is an immunodiagnostic system intended to be used by trained and qualified laboratory professionals, for In vitro Diagnostic (IVD) purpose, veterinary and industrial applications. The mini VIDAS¿ system is intended to execute an immunoassay protocol and to release results according to the package insert of the VIDAS¿ assay kits.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    bioMerieux, Inc., 100 Rodolphe St, Durham NC 27712-9402
  • 제조사 모회사 (2017)
  • Source
    USFDA