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
The TOSOH G7 HPLC automated system analyzer is a fully automated high-performance liquid chromatography instrument that rapidly and precisely separates hemoglobins found naturally in the blood. Glycosylated hemoglobins and other components of hemoglobin are extracted depending on the charge of the molecule in relation to an incremental gradient that pass through a non-porous cationic column. In the mode of HbA1c variant analysis, the predetermined windows are configured in the software to detect the presence of HbA1a, HbA1b, HbF, labile HbA1c (la1c), HbA1c (sa1c), and a0. The reagents that are used with the TOSOH G7 analyzers have a respective health record.