Tosoh Bioscience, Inc.

  • Manufacturer Address
    Tosoh Bioscience, Inc., 347 Oyster Point Blvd Ste 201, South San Francisco CA 94080-1913
  • Source
    USFDA
  • 3 Events

3 devices in the database

  • Model / Serial
    Lot #: DX10789, Expiration Date 10/31/2004
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm distributed product to 10 consumers and 1 distributor, to locations in CA, CO, FL, MD, NY, OH, SC and TX. No federal government agency sales/distribution centers or foreign countries received the product. The last product distributed was on 6/15/2004.
  • Product Description
    Tosoh brand AIA-PACK CA 19-9 Test Cup Set used in TOSOH AIA Immunoassay Analyzers, A pack contains 10 trays of 20 test cups, Catalog #: 020271, For IN VITRO Diagnostic Use, The product is manufactured by TOSOH CORPORATION, TOKYO, JAPAN
  • Model / Serial
    Kit Lot Number: 31205; Controls I & II Lot Numbers: 31009AA, 31010AA
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed to a total of 384 consignees throughout the US as well as Canada, Puerto Rico, Chile and Brazil.
  • Product Description
    Tosoh brand Glycohemoglobin A1c Controls I & II, || Catalog Number: 992133; || Product is distributed by TOSOH Bioscience Inc., 347 Oyster Point Blvd. Suite 201, South San Francisco, CA 94080.
  • Model / Serial
    All units of these models.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    81 customers received the upgrade, including customers who received instruments with the upgrade installed already. 37 customers received the v.3.12 installation. In addition, TOSOH bioscience has identified 3 foreign and 5 US customers who required the upgrade. The firm had distributed to 3 US Government medical centers as well. These upgrades have been completed.
  • Product Description
    TOSOH brand AIA-600 II Enzyme Immunoassay Analyzer; Software version 3.12, Catalog Numbers 019359, 019400; Model 019400, Smart Media