Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of anti-thyroglobulin antibodies (TgAb) in human serum on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of autoimmune thyroid disorders, such as Graves disease and Hashimotos disease. Comment to IU: Please note that the Calibrator set is not part of the IU but required for the assay.
Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, making the calibration unacceptable.
US Nationwide distribution in the states of CA, FL, GA, NY, OH & OR.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1187-2021