The KleeYa® System is a chemiluminescence platform intended for fully automated processing of dedicated immunoassays. This comprises sample processing (sample pre-dilutions, sample and reagent dispensing, incubations, wash processes) as well as quantitative determination of analytes, and evaluation of these measurements. Individual assays are carried out in specific disposable cuvettes. Specimen range is assay dependent and covers serum-like and aqueous-like liquids. Tested for aqueous-like: DI water with CLSI quality, tested for serum-like: 50 mM TRIS, 154 mM NaCl, 4% (w/w) BSA, 20% (v/v) Glycerin, 0.1% Proclin 300.The instrument is controlled via the PC software, allowing the user to control assay processing in an intuitive way and allows simple and quick operation of daily routine jobs.The KleeYa® System is designed for continuous loading and works on a sample-bysample basis.It is intended to be operated by professional, trained users in a laboratory environment.The device must be validated in the specific application in accordance with relevant regulatory requirements, laboratory practice and state-of-the-art, before putting into service and after implementation of changes.For in vitro diagnostics, use of assay kits or kit components on the KleeYa® System is only permitted after appropriate validation.The use and disposal of hazardous substances and potentially infectious material on the KleeYa® System should be the responsibility of the user in accordance with local regulations.
An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers (e.g., protein, drug, hormone, microbial toxin) in a clinical specimen, using an immunological method that utilizes a chemiluminescent detection system together with sample processing, data processing and/or data display software.
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