Bio-Rad 373 Lyphochek Immunoassay Plus Control Level 3

Intended use

Lyphochek Immunoassay Plus Control, Level 3 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. Level 3 provides a high control concentration and is typically run together with Level 1 (Part # 371) for two-level QC. Assigned values are available for most major automated immunoassay analyzers, including Beckman Coulter Access 2 systems. Results are intended for use by trained laboratory professionals as part of the laboratory’s quality control program.

Storage & shelf life

Supplied as 12 x 5 mL vials. 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 instrument-specific target values and acceptable ranges. 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.