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STRATEC SE Registered Devices
Listing registered devices, PMA filings, and compliance records for STRATEC SE.
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The GEMINI is a compact microplate processor designed for the automation of diagnostic ELISA/EIA and autoimmune assays. The instrument is to be used in clinics, laboratories, universities and hospitals containing diagnostic facilities as well as blood banks. The workplace for the instrument shall be a dedicated laboratory (area) for diagnostic purposes. The laboratories are not restricted to, but may include small working spaces (areas).The GEMINI consists of a platform that performs ELISA and similar structured assays, and PC software that performs several instrument tasks and provides a graphical user interface. The GEMINI has an interface that can accommodate with an internal PC. The PC has a data connection to an external laboratory information system (which is not included in the GEMINI). The GEMINI has a loading bay for samples and reagents, and positions for disposable tips. The GEMINI also has a transport system and fixed positions for loading microplates. Loading of any of these items into the GEMINI instrument is to be performed by the operator. Sample and reagent vessels come with attached barcodes that encode the identifier of the corresponding sample or reagent. The GEMINI reads the barcodes and stores the identifier. Barcodes on microplatescannot automatically be scanned by the instrument.The device must be validated in the specific application according to laboratory practice and state-of-the-art before putting into service and after changes. Use of kits or kit components on the GEMINI instrument is only allowed after validation. Using/running hazardous substances on the GEMINI instrument is in the responsibility of the operator.
ID: Compact Microplate Processor
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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.
ID: Fully automated CLIA analyzer
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KleeYa® Instrument
ID: 04260678680003
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Gemini Compact Microplate Processor
ID: 04260678680010
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