Eragen Biosciences, Inc.

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Contact: Randal Vader
Web: http://www.eragen.com
E-Mail:
Address: 918 Deming Way, Suite 201, Madison, Wisconsin 53717, USA
Phone: +1-(608)-6629000 | Fax: +1-(608)-6629003 | Map/Directions >>

Profile: Eragen Biosciences, Inc. deals with clinical laboratories and medical research. Our products are analyte specific reagents, in vitro diagnostic reagents and research use only Reagents. We provide Multicode®-PLx analysis software and MultiCode®-RTx analysis software for quantitative and qualitative analyses and then to view or print the amplification and melt curves in full color. This software allows the user to print customized reports or save the results in a spreadsheet format. Our DNA sample processing control is an unassayed internal extraction and amplification process control in any end-point or real-time polymerase chain reaction assay. This DNA sample processing control is used to detect systemic variation that may arise during the extraction and amplification process associated with end-point or real-time PCR assays. The Multicode®-PLx hybridization solution 555 is used during hybridization of sequencing for the capture of target-specific extension products onto microbeads. The Multicode®-PLx streptavidin R-phycoerythrin is a fluorescent dye used for generating reporter signal in multiplexing assays. Our Multicode®-RTx CMV primer mix RUO contains forward and reverse primers that target the UL54 DNA polymerase gene of CMV. This product also contains forward and reverse primers for detecting a control to monitor the amplification or amplification and extraction processes in any end-point or real-time polymerase chain reaction assay.

The company is ISO 13485 certified.

FDA Registration Number: 3003232610

6 Products/Services (Click for related suppliers)

• Analyte Specific Reagents, Asr Reagents (FDA Code: MVU / 864.4020)

Analyte specific reagents (ASR's) are antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens. ASR's that otherwise fall within this definition are not within the scope of subpart E of this part when they are sold to:

• Computer Softwares

• Diagnostic Reagents

• In Vitro Diagnostic Reagents

• Not Assay Specific Internal Polymerase Chain Reaction Control (FDA Code: OLD / 862.1660)

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

• Research Reagents