Bio-Rad 371 Lypochek immuno+ control Level1

Intended use

Lyphochek Immunoassay Plus Control is an assayed, lyophilized, human serum-based quality control material intended to monitor the precision of laboratory testing procedures for the immunoassay and therapeutic drug monitoring (TDM) analytes listed in the package insert. Levels 1 and 3 provide low and high control concentrations for routine use on Beckman Coulter Access 2 immunoassay systems. Results are intended for use by trained laboratory professionals as part of the laboratory’s quality control program.

Storage & shelf life

Store unopened vials at 2-8 C. Stable until the expiration date printed on the label when stored unopened as directed. Reconstitute each vial with 5.0 mL of distilled or deionized water as directed in the package insert. Once reconstituted, most analytes are stable for 7 days at 2-8 C or 20 days frozen at -20 to -70 C; analyte-specific exceptions are listed in the package insert. Refer to the lot-specific insert for assigned values and acceptable ranges for your instrument. 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 Bio-Rad Laboratories, Inc. Refer to the current manufacturer’s package insert, lot-specific value assignment sheet and Safety Data Sheet (SDS) for the complete procedure, analyte stability exceptions, limitations, warnings and precautions.