Device Recall LeadCare II Blood Lead Testing System

  • 모델명 / 제조번호(시리얼번호)
    All lot codes
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (Nationwide) Foreign: AUSTRALIA AUSTRIA BOLIVIA CANADA CHILE CHINA COLOMBIA DOMINICAN REPUB ENGLAND GERMANY INDIA UK ISRAEL ITALY JAPAN KOREA MALI MYANMAR SPAIN NEPAL NETHERLANDS NEW ZEALAND P.R. CHINA PANAMA US PERU PHILLIPINES POLAND PORTUGAL REP OF KOSOVO SOUTH AFRICA SRI LANKA USA SWEDEN SWITZERLAND TRINIDAD UNITED ARAB EMI VIETNAM
  • 제품 설명
    Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. || Product Usage: || The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of lead in fresh whole blood. This product is for professional use only. Sensors and Treatment Reagent of the Test Kit are specific for lead only. Contents of this LeadCare Blood Lead Test Kit must only be used with a LeadCare Analyzer and Blood Lead Testing System.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Magellan Diagnostics, Inc., 101 Billerica Ave Bldg 4, North Billerica MA 01862-1271
  • 제조사 모회사 (2017)
  • Source
    USFDA