Luminex Corporation

FDA Registration(s)#

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

• luminexcorp.com

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• LIAISON PLEX Gram-Positive Blood Culture Assay

  2025-06-06

  Luminex Corporation

• LIAISON PLEX Gram-Negative Blood Culture Assay

  2025-04-18

  Luminex Corporation

• LIAISON PLEX Yeast Blood Culture Assay

  2024-06-04

  Luminex Corporation

• LIAISON PLEX Respiratory Flex Assay

  2024-03-01

  Luminex Corporation

• ARIES MRSA Assay

  2019-09-25

  Luminex Corporation

• ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit

  2017-10-30

  Luminex Corporation

• ARIES C. Difficile Assay Complete Kit, ARIES C. Difficile Assay Protocol File Kit, ARIES C. Difficile Assay Kit (24 Cassettes), ARIES Stool Resuspension Kit

  2017-07-21

  Luminex Corporation

• ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit

  2017-05-02

  Luminex Corporation

• ARIES GBS Assay

  2016-12-23

  LUMINEX CORPORATION

• ARIES® Flu A/B & RSV Assay

  2016-08-02

  LUMINEX CORPORATION

• ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton Of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)

  2016-06-30

  LUMINEX CORPORATION

• ARIES System

  2016-04-12

  LUMINEX CORPORATION

• ARIES System

  2015-10-06

  LUMINEX CORPORATION

• ARIES HSV 1&2 Assay Cassettes - Carton Of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD)

  2015-10-06

  LUMINEX CORPORATION

GUDID#

• LIAISON PLEX Gastrointestinal Flex Assay - The LIAISON PLEX® Gastrointestinal Flex Assay is an automated and qualitative multiplexed test for simultaneous detection and identification of common pathogenic bacteria, viruses, and parasites from liquid or soft stool preserved in Cary-Blair or modified Cary-Blair medium and additionally for parasites, from liquid or soft stool preserved in alcohol-based formalin-free parasite fixative (e.g., EcoFix®, Total-Fix®) collected from individuals with signs and symptoms of gastrointestinal infection. The test is performed on the automated LIAISON PLEX® System utilizing reverse transcription (RT), polymerase chain reaction (PCR), and array hybridization to detect specific gastrointestinal microbial nucleic acid gene sequences associated with the pathogenic bacteria, viruses, and parasites.

  LUMINEX CORPORATION

  2026-06-08

• Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge - The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples.

  LUMINEX CORPORATION

  2019-12-05

• Hypercoagulation Panel (HC) Sample Buffer - The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples.

  LUMINEX CORPORATION

  2019-12-05

• LIAISON PLEX Gram-Positive Blood Culture Assay - The LIAISON PLEX® Gram-Positive Blood Culture (BCP) Assay, performed using the automated, sample-to-result LIAISON PLEX® System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-positive pathogens and/or selected genetic determinants associated with antimicrobial resistance in positive blood culture bottles.

  LUMINEX CORPORATION

  2025-07-11

• LIAISON PLEX Yeast Blood Culture Assay Kit - The LIAISON PLEX® Yeast Blood Culture (BCY) Assay is a qualitative nucleic acid multiplex in vitro diagnostic test intended for use on the LIAISON PLEX® System for simultaneous detection and identification of multiple potentially pathogenic fungal organisms in positive blood culture.

  LUMINEX CORPORATION

  2024-10-22

• LIAISON PLEX® Respiratory Flex Assay Kit - The LIAISON PLEX® Respiratory Flex (RSP Flex) Assay is a multiplexed qualitative test for the simultaneous in vitro detection and identification of multiple bacterial and viral nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals with clinical signs and symptoms of respiratory tract infection, including SARS-CoV-2.

  LUMINEX CORPORATION

  2024-06-20

• LIAISON PLEX Gram-Negative Blood Culture Assay - The LIAISON PLEX® Gram-Negative Blood Culture (BCN) Assay, performed using the automated, sample-to-result LIAISON PLEX® System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative pathogens and/or selected genetic determinants associated with antimicrobial resistance in positive blood culture bottles.

  LUMINEX CORPORATION

  2025-06-11

• MHV Control Primers 5 - Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

  LUMINEX CORPORATION

  2016-12-16

• MultiCode® Chlamydophila pneumoniae Primers - Nucleic acid sequences, 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

  LUMINEX CORPORATION

  2016-12-16

• MultiCode® Legionella pneumophila Primers - Nucleic acid sequences, 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

  LUMINEX CORPORATION

  2016-12-16

• MultiCode® Mycoplasma pneumoniae Primers - Nucleic acid sequences, 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

  LUMINEX CORPORATION

  2016-12-16

• MHV DNA Sample Processing Control - Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

  LUMINEX CORPORATION

  2016-12-16

• MHV DNA Sample Processing Control - Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

  LUMINEX CORPORATION

  2016-12-16

• MHV DNA Sample Processing Control - Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

  LUMINEX CORPORATION

  2016-12-16

• MHV DNA Sample Processing Control - Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

  LUMINEX CORPORATION

  2016-12-16

• MHV DNA Sample Processing Control - Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

  LUMINEX CORPORATION

  2016-12-16

• MHV DNA Amplification Control - Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

  LUMINEX CORPORATION

  2016-12-16

• MHV Control Primers 1 - Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

  LUMINEX CORPORATION

  2016-12-16

• MHV Control Primers 2 - Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

  LUMINEX CORPORATION

  2016-12-16

• MHV Control Primers 2 - Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

  LUMINEX CORPORATION

  2016-12-16

• MHV Control Primers 3 - Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

  LUMINEX CORPORATION

  2016-12-16

• MHV Control Primers 3 - Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

  LUMINEX CORPORATION

  2016-12-16

• MultiCode® HSV Primers - Nucleic acid sequences, 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

  LUMINEX CORPORATION

  2016-12-16

• MultiCode® Bordetella pertussis Primers - Nucleic acid sequences, 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

  LUMINEX CORPORATION

  2016-12-16

• MultiCode® Bordetella parapertussis Primers - Nucleic acid sequences, 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

  LUMINEX CORPORATION

  2016-12-16

• MultiCode® Enterovirus Primers - Nucleic acid sequences, 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

  LUMINEX CORPORATION

  2016-12-16

• MultiCode® CMV Primers - Nucleic acid sequences, 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

  LUMINEX CORPORATION

  2016-12-16

• MultiCode® BK Virus Primers - Nucleic acid sequences, 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

  LUMINEX CORPORATION

  2016-12-16

• MultiCode® EBV Primers - Nucleic acid sequences, 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

  LUMINEX CORPORATION

  2016-12-16

• MultiCode® Candida albicans Primers - Nucleic acid sequences, 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

  LUMINEX CORPORATION

  2016-12-16

• MultiCode® Gardnerella vaginalis Primers - Nucleic acid sequences, 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

  LUMINEX CORPORATION

  2016-12-16

• MultiCode® Adenovirus Primers - Nucleic acid sequences, 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

  LUMINEX CORPORATION

  2016-12-16

• MultiCode® VZV Primers - Nucleic acid sequences, 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

  LUMINEX CORPORATION

  2016-12-16

• MultiCode® Atopobium vaginae Primers - Nucleic acid sequences, 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

  LUMINEX CORPORATION

  2016-12-16

• MultiCode® Candida glabrata Primers - Nucleic acid sequences, 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

  LUMINEX CORPORATION

  2016-12-16

• MultiCode® Trichomonas vaginalis Primers - Nucleic acid sequences, 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

  LUMINEX CORPORATION

  2016-12-16

• MHV Control Primers 4 - Internal control used in real-time polymerase chain reaction (pcr) assays to detect systemic variation that may arise during the extraction and amplification process associated with real-time pcr assays. It is not intended to monitor other real-time pcr processes.

  LUMINEX CORPORATION

  2016-12-16

• Multicode® Mycoplasma genitalium Primers - Nucleic acid sequences, 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

  LUMINEX CORPORATION

  2017-11-07

• ARIES® C. difficile Assay - The ARIES® C. difficile Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Clostridium difficile (C. difficile) nucleic acid in unformed (liquid or soft) stool specimens obtained from patients suspected of having Clostridium difficile infection (CDI).

  LUMINEX CORPORATION

  2017-07-25

• ARIES® Extraction Kit - The ARIES® Extraction Kit is intended to extract nucleic acid from human biological specimens and universal transport media (UTM).

  LUMINEX CORPORATION

  2016-12-16

108 records. Showing 1-40. Next