Device Recall AFP ELISA Kit

  • Model / Serial
    Catalog number: BC-1009; RN-34412 06-2010  RN-34387 06-2010 RN-34984 06-2010 RN-35612 10-2010  RN-36335 10-2010 RN-36637 01-2011 RN-37019 01-2011 RN-37374 03-2011 RN-38064 06-2011 RN-39414 09-2011  RN-39415 09-2011 RN-39948 12-2011 RN-40343 02-2012  Catalog number: BC-1010: RN-34226 05-2010  RN-34818 07-2010 RN-35158 09-2010 RN-35869 11-2010  RN-36129 12-2010 RN-37597 04-2011 RN-39545 10-2011  RN-39947 12-2011 RN-40304 02-2012 RN-40845 02-2012.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution.
  • Product Description
    AFP ELISA Kit; || AFP ELISA kit (Extended range); || BioCheck, Foster City, CA 94404 || Quantitative determination of AFP concentration in human serum.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    BioCheck Inc, 323 Vintage Park Dr, Foster City CA 94404-1186
  • Manufacturer Parent Company (2017)
  • Source
    USFDA