Luminex Corp

FDA Filings

This page includes the latest FDA filings for Luminex Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

USANASDAQLMNXDUNS 965476641

Luminex Corp holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3003232610
FEI Number3003232610
NameLuminex Corporation
Owner & OperatorLuminex Corporation
Contact Address12212 Technology Blvd.
Austin TX 78727 US
Official Correspondent
  • Steven Back
  • x-512-3813296-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1224 Deming Way
Madison, WI 53717 US
Establishment TypeManufacture Medical Device



Registration Number3002777243
FEI Number3002777243
NameSteven Back
Owner & OperatorLuminex Corporation
Contact Address12212 Technology Blvd.
Austin TX 78727 US
Official Correspondent
  • Steven Back
  • x-512-3813296-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address12212 TECHNOLOGY BLVD.
AUSTIN, TX 78727 US
Establishment TypeManufacture Medical Device



Registration Number1650733
FEI Number3002524000
NameLuminex Corporation
Owner & OperatorLuminex Corporation
Contact Address12212 Technology Blvd.
Austin TX 78727 US
Official Correspondent
  • Steven Back
  • x-512-3813296-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address12212 Technology Blvd
AUSTIN, TX 78727 US
Establishment TypeManufacture Medical Device



Registration Number3006028115
FEI Number3006028115
NameLuminex Corporation
Owner & OperatorLuminex Corporation
Contact Address12212 Technology Blvd.
Austin TX 78727 US
Official Correspondent
  • Steven Back
  • x-512-3813296-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address4088 Commercial Avenue
Northbrook, IL 60062 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
LUMINEX CORPORATION
xMAP® Sheath Fluid PLUS 2022-09-16
LUMINEX CORPORATION
MAGPIX® Drive Fluid PLUS (4PK) 2022-09-16
LUMINEX CORPORATION
xMAP® Sheath Concentrate PLUS 2021-03-08
LUMINEX CORPORATION
VERIGENE® II Module 2019-12-25
LUMINEX CORPORATION
VERIGENE® II System 2019-12-25
Steven Back [Luminex Corporation]
NxTAG? Respiratory Pathogen Panel2019-12-23
Steven Back [Luminex Corporation]
xTAG? Gastrointestinal Pathogen Panel (GPP)2019-11-14
Steven Back [Luminex Corporation]
xTAG? Gastrointestinal Pathogen Panel (GPP)2019-11-14
LUMINEX CORPORATION
ARIES® MRSA Assay 2019-10-16
Luminex Corporation
ARIES MRSA Assay2019-10-04
Luminex Corporation
ARIES MRSA Assay2019-09-25
Luminex Corporation
VERIGENE II Instrument2019-07-25
Luminex Corporation
MAGPIX2019-07-25
Steven Back [Luminex Corporation]
xTAG? Gastrointestinal Pathogen Panel (GPP)2018-12-03
Steven Back [Luminex Corporation]
xTAG? Data Analysis Software (TDAS GPP)2018-12-03
Steven Back [Luminex Corporation]
xTAG? Gastrointestinal Pathogen Panel (GPP)2018-12-03
Steven Back [Luminex Corporation]
xTAG? Data Analysis Software (TDAS GPP)2018-12-03
LUMINEX CORPORATION
ARIES® System 2018-07-06
LUMINEX CORPORATION
ARIES® Group A Strep Assay 2018-07-06
LUMINEX CORPORATION
ARIES® Bordetella Assay 2018-07-06
LUMINEX CORPORATION
MAGPIX® Drive Fluid 2018-07-06
LUMINEX CORPORATION
SYNCT™ Software 2018-07-06
LUMINEX CORPORATION
FLEXMAP 3D® Calibration Kit 2018-07-06
LUMINEX CORPORATION
FLEXMAP 3D® Performance Verification Kit 2018-07-06
LUMINEX CORPORATION
Luminex® 100/200™ Calibration Kit 2018-07-06
LUMINEX CORPORATION
Luminex® 100/200™ Performance Verification Kit 2018-07-06
LUMINEX CORPORATION
FLEXMAP 3D® 2018-07-06
LUMINEX CORPORATION
ARIES® HSV 1&2 Assay 2018-07-06
LUMINEX CORPORATION
MAGPIX® Performance Verification Kit 2018-07-06
LUMINEX CORPORATION
MAGPIX® Calibration Kit 2018-07-06
LUMINEX CORPORATION
MAGPIX® 2018-07-06
LUMINEX CORPORATION
ARIES® GBS Assay 2018-07-06
LUMINEX CORPORATION
ARIES® Flu A/B & RSV Assay 2018-07-06
LUMINEX CORPORATION
Luminex® 100/200™ 2018-07-06
LUMINEX CORPORATION
xMAP® Sheath Concentrate Pack 2018-07-06
LUMINEX CORPORATION
xMAP® Sheath Fluid 2018-07-06
LUMINEX CORPORATION
ARIES® M1 System 2018-07-06
LUMINEX CORPORATION
ARIES® Extraction Kit 2018-07-06
LUMINEX CORPORATION
ARIES® C. difficile Assay 2018-07-06
LUMINEX CORPORATION
Multicode® Mycoplasma genitalium Primers 39282018-03-29
LUMINEX CORPORATION
MHV Control Primers 4 38052018-03-29
LUMINEX CORPORATION
MultiCode® Trichomonas vaginalis Primers 39202018-03-29
LUMINEX CORPORATION
MultiCode® Candida glabrata Primers 39192018-03-29
LUMINEX CORPORATION
MultiCode® Atopobium vaginae Primers 39182018-03-29
LUMINEX CORPORATION
MultiCode® VZV Primers 39162018-03-29
LUMINEX CORPORATION
MultiCode® Influenza A Primers 39132018-03-29
LUMINEX CORPORATION
MultiCode® Adenovirus Primers 39142018-03-29
LUMINEX CORPORATION
MultiCode® Gardnerella vaginalis Primers 39122018-03-29
LUMINEX CORPORATION
MultiCode® Candida albicans Primers 39112018-03-29
LUMINEX CORPORATION
MultiCode® EBV Primers 3909-212018-03-29
LUMINEX CORPORATION
MultiCode® EBV Primers 39092018-03-29
LUMINEX CORPORATION
MultiCode® BK Virus Primers 3908-212018-03-29
LUMINEX CORPORATION
MultiCode® BK Virus Primers 39082018-03-29
LUMINEX CORPORATION
MultiCode® Influenza B Primers 39052018-03-29
LUMINEX CORPORATION
MultiCode® CMV Primers 3906-212018-03-29
LUMINEX CORPORATION
MultiCode® CMV Primers 39062018-03-29
LUMINEX CORPORATION
MultiCode® Enterovirus Primers 39032018-03-29
LUMINEX CORPORATION
MultiCode® Bordetella parapertussis Primers 39022018-03-29
LUMINEX CORPORATION
MultiCode® Bordetella pertussis Primers 39012018-03-29
LUMINEX CORPORATION
MultiCode® HSV Primers 39002018-03-29
LUMINEX CORPORATION
MHV Control Primers 3 3804-222018-03-29
LUMINEX CORPORATION
MHV Control Primers 3 3804-212018-03-29
LUMINEX CORPORATION
MHV Control Primers 3 38042018-03-29
LUMINEX CORPORATION
MHV Control Primers 2 3803-212018-03-29
LUMINEX CORPORATION
MHV Control Primers 2 38032018-03-29
LUMINEX CORPORATION
MHV Control Primers 1 3802-212018-03-29
LUMINEX CORPORATION
MHV Control Primers 1 38022018-03-29
LUMINEX CORPORATION
MHV RNA Amplification Control 3695-212018-03-29
LUMINEX CORPORATION
MHV RNA Amplification Control 36952018-03-29
LUMINEX CORPORATION
MHV DNA Amplification Control 3694-222018-03-29
LUMINEX CORPORATION
MHV DNA Amplification Control 3694-212018-03-29
LUMINEX CORPORATION
MHV DNA Amplification Control 36942018-03-29
LUMINEX CORPORATION
MHV DNA Sample Processing Control 3710-212018-03-29
LUMINEX CORPORATION
MHV DNA Sample Processing Control 37102018-03-29
LUMINEX CORPORATION
MHV DNA Sample Processing Control 3700-222018-03-29
LUMINEX CORPORATION
MHV DNA Sample Processing Control 3700-212018-03-29
LUMINEX CORPORATION
MHV DNA Sample Processing Control 3700-022018-03-29
LUMINEX CORPORATION
MHV DNA Sample Processing Control 37002018-03-29
LUMINEX CORPORATION
Mutlicode®-RTx HSV 1&2 Kit 37112018-03-29
LUMINEX CORPORATION
MultiCode® Mycoplasma pneumoniae Primers 39272018-03-29
LUMINEX CORPORATION
MultiCode® Legionella pneumophila Primers 39262018-03-29
LUMINEX CORPORATION
MultiCode® Chlamydophila pneumoniae Primers 39252018-03-29
LUMINEX CORPORATION
MultiCode® Group A Strep Primers 39232018-03-29
LUMINEX CORPORATION
MultiCode® Fusobacterium Primers 39222018-03-29
LUMINEX CORPORATION
MultiCode® Bordetella holmseii Primers 39212018-03-29
LUMINEX CORPORATION
MHV Control Primers 5 38062018-03-29
Luminex Corporation
ARIES Group A Strep Assay2017-11-02
Luminex Corporation
ARIES Group A Strep Assay2017-11-02
Luminex Corporation
ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit2017-10-30
Steven Back [Luminex Corporation]
xTAG CYP2D6 Kit V32017-08-14
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 Kit2017-07-21
Luminex Corporation
ARIES System2017-07-21
Luminex Corporation
ARIES M1 System2017-07-21
Luminex Corporation
ARIES C. difficile Assay2017-07-21
Luminex Corporation
ARIES System2017-07-21
Luminex Corporation
ARIES M1 System2017-07-21
Luminex Corporation
ARIES C. difficile Assay2017-07-21
Luminex Corporation
ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit2017-05-02
Luminex Corporation
ARIES Bordetella Assay2017-05-02
Steven Back [Luminex Corporation]
Xtag Cystic Fibrosis 39 Kit V22017-02-03
Steven Back [Luminex Corporation]
Xtag Cystic Fibrosis 60 Kit V22017-02-03
Luminex Corporation
ARIES System2017-01-04
Luminex Corporation
ARIES M1 System2017-01-04
Luminex Corporation
ARIES GBS Assay2017-01-04
Luminex Corporation
ARIES System2017-01-04
Luminex Corporation
ARIES M1 System2017-01-04
Luminex Corporation
ARIES GBS Assay2017-01-04
LUMINEX CORPORATION
ARIES GBS Assay2016-12-23
Luminex Corporation
Verigene System2016-08-16
Luminex Corporation
Verigene System2016-08-16
Luminex Corporation
Verigene System2016-08-16
Luminex Corporation
Verigene System2016-08-16
Luminex Corporation
Verigene System2016-08-16
Luminex Corporation
Verigene System2016-08-16
Luminex Corporation
Verigene System2016-08-16
Luminex Corporation
Verigene Enteric Pathogens Nucleic Acid Test (EP); Verigene EP2016-08-16
Luminex Corporation
Verigene Enteric Pathogens Nucleic Acid Test (EP); Verigene EP2016-08-16
Luminex Corporation
Verigene Enteric Pathogens Nucleic Acid Test (EP); Verigene EP2016-08-16
Luminex Corporation
Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN)2016-08-16
Luminex Corporation
Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN)2016-08-16
Luminex Corporation
Verigene CDF Nucleic Acid Test2016-08-16
Luminex Corporation
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test2016-08-16
Luminex Corporation
Verigene 2C19 Nucleic Acid Test2016-08-16
Luminex Corporation
Verigene 2C19 Nucleic Acid Test2016-08-16
Luminex Corporation
Verigene BC-S Nucleic Acid Test2016-08-16
Luminex Corporation
Verigene BC-S Nucleic Acid Test2016-08-16
Luminex Corporation
Verigene System2016-08-16
Luminex Corporation
Verigene System2016-08-16
Luminex Corporation
Verigene System2016-08-16
Luminex Corporation
Verigene System2016-08-16
Luminex Corporation
Verigene System2016-08-16
Luminex Corporation
Verigene System2016-08-16
Luminex Corporation
Verigene RV+ Nucleic Acid Test2016-08-16
Luminex Corporation
Verigene RV+ Nucleic Acid Test2016-08-16
Luminex Corporation
Verigene CF Nucleic Acid Test2016-08-16
Luminex Corporation
Verigene System2016-08-16
Luminex Corporation
Verigene System2016-08-16
Luminex Corporation
Verigene Warfarin Nucleic Acid Test2016-08-16
Luminex Corporation
Verigene Warfarin Nucleic Acid Test2016-08-16
Luminex Corporation
Verigene Warfarin Nucleic Acid Test2016-08-16
Luminex Corporation
Verigene HC Nucleic Acid Test2016-08-16
Luminex Corporation
Verigene HC Nucleic Acid Test2016-08-16
Luminex Corporation
Verigene HC Nucleic Acid Test2016-08-16
Luminex Corporation
Verigene HC Nucleic Acid Test2016-08-16
Luminex Corporation
Verigene BC-GP Nucleic Acid Test2016-08-16
Luminex Corporation
ARIES? M1 System2016-08-08
Luminex Corporation
ARIES? HSV 1&2 Assay2016-08-08
Luminex Corporation
ARIES? M1 System2016-08-08
Luminex Corporation
ARIES? HSV 1&2 Assay2016-08-08
Luminex Corporation
ARIES? Flu A/B & RSV Assay2016-08-08
Luminex Corporation
ARIES? Flu A/B & RSV Assay2016-08-08
Luminex Corporation
ARIES? Flu A/B & RSV Assay2016-08-08
LUMINEX CORPORATION
ARIES® Flu A/B & RSV Assay2016-08-02
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
SYNCT2016-05-05
Luminex Corporation
ARIES System2016-05-05
Luminex Corporation
ARIES Extraction Kit2016-05-05
LUMINEX CORPORATION
ARIES System2016-04-12
Steven Back [Luminex Corporation]
NxTAG Respiratory Pathogen Panel2016-01-21
Luminex Corporation
NxTAG Respiratory Pathogen Panel2016-01-21
Luminex Corporation
ARIES? System2015-12-17
Luminex Corporation
ARIES? HSV 1&22015-12-17
Luminex Corporation
ARIES? HSV 1&22015-12-17
LUMINEX CORPORATION
ARIES System2015-10-06
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
Steven Back [Luminex Corporation]
xTAG Gastrointestinal Pathogen Panel2014-11-11
Steven Back [Luminex Corporation]
xTAG Gastrointestinal Pathogen Panel2014-09-25
Steven Back [Luminex Corporation]
xTAG GPP2014-09-25
Luminex Corporation
FLEXMAP 3D2014-01-24
LUMINEX CORP.
FLEXMAP 3D2014-01-10
Steven Back [Luminex Corporation]
xTAG CYP2C19 KIT V32013-11-01
Steven Back [Luminex Corporation]
xTAG CYP2D6 Kit v32013-05-28
Steven Back [Luminex Corporation]
Gastrointestinal Pathogen Panel (GPP)2013-05-13
Luminex Corporation
Gastrointestinal Pathogen Panel (GPP)2013-05-13
Steven Back [Luminex Corporation]
Gastrointestinal Pathogen Panel (GPP)2013-05-13
Luminex Corporation
Gastrointestinal Pathogen Panel (GPP)2013-05-13
Steven Back [Luminex Corporation]
Gastrointestinal Pathogen Panel (GPP)2013-05-13
Luminex Corporation
Gastrointestinal Pathogen Panel (GPP)2013-05-13
Luminex Corporation
FLEXMAP 3D2013-05-13
Steven Back [Luminex Corporation]
Gastrointestinal Pathogen Panel (GPP)2013-05-13
LUMINEX CORP.
LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P2013-01-09
Luminex Corporation
MultiCode-RTx HSV 1&2 Kit2012-03-28
Luminex Corporation
MultiCode-RTx HSV 1&2 Kit Analysis Software2012-03-28
Luminex Corporation
MHV RNA Sample Processing Control2012-03-28
Luminex Corporation
MHV RNA Amplification Control2012-03-28
Luminex Corporation
MHV DNA Sample Processing Control2012-03-28
Luminex Corporation
MHV DNA Amplification Control2012-03-28
Luminex Corporation
MHV Control Primers 52012-03-28
Luminex Corporation
MHV Control Primers 42012-03-28
Luminex Corporation
MHV Control Primers 32012-03-28
Luminex Corporation
MHV Control Primers 22012-03-28
Luminex Corporation
MHV Control Primers 12012-03-28
Steven Back [Luminex Corporation]
xTAG CYP2D6 Kit v32011-10-17
Steven Back [Luminex Corporation]
xTAG Cystic Fibrosis 39 kit v22010-06-15
Steven Back [Luminex Corporation]
xTAG Cystic Fibrosis 60 kit v22010-06-15
Luminex Corporation
Luminex 2002008-04-16
Luminex Corporation
Luminex 1002008-04-16
Luminex Corporation
Luminex 100/2002008-04-16
LUMINEX CORP.
LUMINEX LX 100/200 INSTRUMENT2008-03-07
Steven Back [Luminex Corporation]
xTAG Respiratory Viral Panel2008-02-01
Steven Back [Luminex Corporation]
xTAG2004-04-09
Steven Back [Luminex Corporation]
TAG-IT2004-04-09
Luminex Corporation
MultiCode2004-04-09
Luminex Corporation
MultiCode VZV Primers2004-04-09
Luminex Corporation
MultiCode Trichomonas vaginalis Primers2004-04-09
Luminex Corporation
MultiCode Mycoplasma pneumoniae Primers2004-04-09
Luminex Corporation
MultiCode Mycoplasma genitalium Primers2004-04-09
Luminex Corporation
MultiCode Legionella pneumophila Primers2004-04-09
Luminex Corporation
MultiCode HSV Primers2004-04-09
Luminex Corporation
MultiCode Group A Strep Primers2004-04-09
Luminex Corporation
MultiCode Gardnerella vaginalis Primers2004-04-09
Luminex Corporation
MultiCode Fusobacterium Primers2004-04-09
Luminex Corporation
MultiCode Enterovirus Primers2004-04-09
Luminex Corporation
MultiCode EBV Primers2004-04-09
Luminex Corporation
MultiCode Chlamydophia pneumoniae Primers2004-04-09
Luminex Corporation
MultiCode Candida glabrata Primers2004-04-09
Luminex Corporation
MultiCode Candida albicans Primers2004-04-09
Luminex Corporation
MultiCode CMV Primers2004-04-09
Luminex Corporation
MultiCode Bordetella pertussis Primers2004-04-09
Luminex Corporation
MultiCode Bordetella parapertussis Primers2004-04-09
Luminex Corporation
MultiCode Bordetella holmseii Primers2004-04-09
Luminex Corporation
MultiCode BV Virus Primers2004-04-09
Luminex Corporation
MultiCode Atopobium vaginae Primers2004-04-09
Luminex Corporation
MultiCode Adenovirus Primers2004-04-09

Related Finance Registrations

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.