Intended use The Access Thyroglobulin assay is a paramagnetic particle, chemiluminescent immunoassay intended for the quantitative determination of thyroglobulin (Tg) in human serum and plasma, using the Beckman Coulter Access Immunoassay Systems (Access 2, UniCel DxI 600/800, DxI 9000). Results are intended for use by trained laboratory professionals in conjunction with other clinical and laboratory findings. 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.