Intended use Access Thyroglobulin Calibrators are intended for the calibration of the thyroglobulin assay on the Beckman Coulter Access Immunoassay Systems (Access 2, UniCel DxI 600/800, DxI 9000). Calibrators establish the relationship between measured assay signal and analyte concentration and must be run at the frequency and in the manner described in the assay package insert. Not for use as a quality control material. Storage & shelf life Store upright at 2-10 C in the original packaging. Do not freeze. Stable until the expiration date printed on the label when stored unopened as directed; on-board, opened-pack and post-calibration stability are as stated in the package insert. Bring to operating temperature and mix as directed before loading. COLD CHAIN: YES - ships refrigerated (2-10 C) with gel packs. Regulatory status For In Vitro Diagnostic Use. For prescription / professional laboratory use only. Manufactured by Beckman Coulter, Inc. Refer to the current manufacturer's Instructions for Use (IFU) and Safety Data Sheet (SDS) for the complete procedure, performance characteristics, limitations, warnings and precautions.
