Luminex Corporation

Address: 12212 Technology Blvd, Austin, Texas 78727, USA
Phone: +1-(512)-219-8020, 888-219-8020 | Fax: +1-(512)-219-5195 | Map/Directions >>

Profile: Luminex Corporation develops, manufactures and markets innovative biological testing technologies with applications in the life-science and diagnostic industry. Our open-architecture xMAP® technology enables large numbers of biological tests (bioassays) to be conducted and analyzed quickly, cost-effectively and accurately. Our product categories are instruments, software solutions, reagents, assays and maintenance parts. Our Luminex® 100/200™ is a flexible analyzer based on the principles of flow cytometry, that is designed to meet the needs of laboratory medicine and the care of patients, as well as being used in the research environment. It has features such as xMAP technology, small sample size, versatility, template-based software, reproducibility and accuracy. Our xTAG® cystic fibrosis kit, is a device used to simultaneously detect and identify a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in human blood specimens. It is a qualitative genotyping test, which provides information intended to be used for carrier testing in adults of reproductive age, as an aid in newborn screening, and in confirmatory diagnostic testing in the newborn, and in children.

FDA Registration Number: 3007279404
US Agent: Norman Black
Phone: +1-(770)-414-4880  Fax: +1-(770)-414-4879  E-Mail:

10 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
• Gene Mutation Detection, Cystic Fibrosis Transmembrane Conductance Regulator System (FDA Code: NUA / 866.5900)
• General Purpose Reagent (FDA Code: LDT)
• Instrumentation For Clinical Multiplex Test Systems (FDA Code: NSU / 862.2570)
• Laboratory Equipment
• Laboratory Equipment Devices
• Medical Software Solutions
• Respiratory Virus Panel Nucleic Acid Assay System (FDA Code: OCC / 866.3980)
A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses:
• Streptococcal Multiple Exoenzyme Test (FDA Code: GTP / 866.3720)

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