Intended use Specific Gravity Calibrator (10 mL) is intended for the calibration of the urine specific gravity assay on Beckman Coulter AU / Olympus AU series clinical chemistry analyzers. 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 unopened at 2-8 C. Do not freeze. Protect from light where indicated on the label. Stable until the expiration date printed on the label when stored as directed; on-board and opened-bottle stability are as stated in the package insert. COLD CHAIN: YES - ships refrigerated (2-8 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.