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The Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer are in vitro diagnostic devices intended for detection of fluorescently-labeled human genomic deoxyribonucleic acid (DNA) nucleotides by capillary electrophoresis. The Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer are indicated for sequencing and fragment analysis using FDA- cleared or approved assays.

The Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer are fluorescence-based DNA analysis instruments that use capillary electrophoresis technology with 8 and 24 capillaries, respectively. The 8-capillary system and the 24-capillary system include the following components: - 8-capillary or 24-capillary array and POP™ polymer . - . Consumables for system qualification - Computer workstation and monitor - Integrated software for instrument control, data collection, quality control, . basecalling and sizecalling of samples The following consumables (branded with the Applied Biosystems name) are required to operate the Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer. - . 50cm Capillary Array: enable the labeled DNA fragments to migrate from the cathode toward the anode for detection - POP-6TM Polymer: used as a separation matrix to separate DNA fragments by size ● during electrophoresis for sequencing - POP-7TM Polymer: used as a separation matrix for separating DNA fragments by size during electrophoresis for fragment analysis - Hi-Di™ Formamide: sample re-suspension solution used for electrokinetic ● injection and denaturing the DNA - Sequencing Standard v1.1: used for spectral calibration of the instrument and instrument performance check - Cathode Buffer Container: pre-filled with running buffer which maintains a source . of ions and the correct pH for electrophoresis - Anode Buffer Container: pre-filled with running buffer which maintains a source ● of ions and the correct pH for electrophoresis - Conditioning Reagent: pre-filled pouch used for priming the polymer pump, ● washing the pump between polymer type changes, and during instrument shutdown - DS-30 Matrix Standard Dx: used for spectral calibration ● - DS-33 Matrix Standard - Dx: used for spectral calibration - DS-33 GeneScan™ Install Kit Dx: used for instrument operational qualification ● - GeneScan™ 600 LIZ® Size Standard v2.0 Dx: used as a ladder for sizing DNA ● fragments - Other accessories (e.g. sample plate holders, plate retainers, septa) .