Device Recall H pylori IgG ELISA kit

  • 모델명 / 제조번호(시리얼번호)
    Catalog number: BC-1051: RN-33907 01-2010 RN-34784 07-2010 RN-34789 07-2010  RN-35133 08-2010 RN-35143 07-2010 RN-35917 10-2010  RN-36411 10-2010 RN-37353 12-2010 RN-37354 04-2011  RN-37356 12-2010 RN-38063 04-2011 RN-39274 09-2011  RN-39674 09-2011 RN-40182 01-2012 RN-40521 03-2012  RN-41405 03-2012 RN-39118 06-2011 RN-39460 10-2011  RN-39814 11-2011 RN-39909 08-2011 RN-39910 09-2011  RN-39911 07-2011 RN-40112 12-2011 RN-40361 02-2012  RN-40363 02-2012 RN-41005 04-2012 RN-41217 04-2012  RN-41229 04-2012 RN-41287 05-2012;   Catalog number: BC-1052: RN-34225 01-2010 RN-34419 06-2010 RN-34700 07-2010  RN-35092 08-2010 RN-35674 10-2010 RN-36038 11-2010  RN-36115 11-2010 RN-36829 11-2010 RN-37222 11-2010  RN-37390 11-2010 RN-37737 02-2011 RN-37738 03-2011  RN-37739 03-2011 RN-38061 06-2011 RN-38156 07-2011  RN-39119 09-2011 RN-39145 08-2011 RN-39813 11-2011  RN-40113 12-2011 RN-40733 12-2011 RN-41004 12-2011 RN-41205 04-2012 RN-41206 04-2012 RN-41215 05-2012  RN-41216 04-2012;  Catalog number BC-1053: RN-34105 04-2010 RN-34110 02-2010 RN-34511 05-2010  RN-34931 07-2010 RN-35033 05-2010 RN-35090 08-2010  RN-35204 08-2010 RN-35454 09-2010 RN-35455 09-2010  RN-35890 10-2010 RN-36627 01-2011 RN-36997 02-2011  RN-37691 03-2011 RN-38253 03-2011 RN-38323 03-2011  RN-38870 07-2011 RN-38874 07-2011 RN-39280 09-2011  RN-39611 10-2011 RN-40408 01-2012 RN-41057 02-2012.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution.
  • 제품 설명
    H pylori IgG ELISA kit (Qualitative) || H pylori IgG ELISA kit (Quantitive) || H pylori IgG 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