Device Recall HSV1 IgG ELISA kit

  • 모델명 / 제조번호(시리얼번호)
    Catalog number: BC-1093: RN-33786 03-2010 RN-33956 03-2010 RN-34538 03-2010  RN-35037 08-2010 RN-35242 09-2010 RN-36114 12-2010  RN-37937 03-2011 RN-38809 07-2011 RN-38839 06-2011  RN-39279 09-2011 RN-40515 02-2012 RN-40515A 02-2012  N-40833 02-2012 RN-40835 02-2012 RN-41271 02-2012  RN-41301 02-2012 RN-41357 02-2012;  Catalog number BC-1095:  RN-33990 04-2010 RN-34548 02-2010 RN-34904 04-2010  RN-35427 09-2010 RN-35807 10-2010 RN-35889 10-2010  RN-37713 03-2011 RN-38218 04-2011 RN-38875 07-2011  RN-39471 10-2011 RN-40226 10-2011 RN-40226A 10-2011  RN-40516 03-2012 RN-40942 03-2012 RN-41214 03-2012.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution.
  • 제품 설명
    HSV-1 IgG ELISA kit ; || HSV-1 IgM ELISA kit; || BioCheck, Foster City, CA 9440. || Quantitative determination of AFP concentration in human serum.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    BioCheck Inc, 323 Vintage Park Dr, Foster City CA 94404-1186
  • 제조사 모회사 (2017)
  • Source
    USFDA