Intended use Access Substrate is a system solution intended for use with the Beckman Coulter Access Immunoassay Systems (Access 2, UniCel DxI 600/800, DxI 9000) to provide the chemiluminescent substrate that generates the light signal measured by every Access assay. It does not measure an analyte and does not by itself produce a patient result; correct performance of the assays run on the system depends on it being loaded, primed and replaced as described in the operator's manual. Storage & shelf life Store at 15-30 C unless a different range is stated on the product label. Do not freeze. Keep containers tightly closed and protect from contamination and direct sunlight. Stable until the expiration date printed on the label; in-use / on-board stability is as stated in the package insert. COLD CHAIN: NO - ships ambient. Regulatory status System solution supplied for use with the in vitro diagnostic system identified above. It does not measure an analyte and does not by itself generate a patient result; it is required for correct operation of the assays run on the system. 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.