Luminex Molecular Diagnostics, Inc.

Luminex Molecular Diagnostics, Inc. — FDA 510(k) Submissions

Luminex Molecular Diagnostics, Inc. has submitted 26 FDA 510(k) premarket notifications since 2008, of which 22 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Respiratory Virus Panel Nucleic Acid Assay System, Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System, System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection, Drug Metabolizing Enzyme Genotyping Systems, Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents . Use the specialty filter in the sidebar to narrow results.