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Luminex Corporation

Matched from indexed company URL: LUMINEX CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
16507333002524000Luminex Corporation1N2026-01-0112212 Technology Blvd AUSTIN TX US 78727
30027772433002777243LUMINEX MOLECULAR DIAGNOSTICS, INC.1N2026-01-01439 UNIVERSITY AVE. TORONTO Ontario CA M5G 1Y8
30060281153006028115Luminex Corporation1N2026-01-014088 Commercial Avenue Northbrook IL US 60062
30032326103003232610Luminex Corporation1N2020-04-251224 Deming Way Madison WI US 53717

GUDID Contact Samples#

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

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00840487100127MHV 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.+1(866)327-3290support@luminexcorp.com
00840487101438LIAISON 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.877-785-2323support@luminexcorp.com
00840487101513Hypercoagulation 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.+1(877)785-2323support@luminexcorp.com
00840487101728Hypercoagulation 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.+1(877)785-2323support@luminexcorp.com
00840487101841LIAISON 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.877-785-2323support@luminexcorp.com
00840487101858LIAISON 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.877-785-2323support@luminexcorp.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1980271204281811K253722LIAISON PLEX Gastrointestinal Flex AssayPCH2026-05-19
1980271129659014K243490LIAISON PLEX Gram-Positive Blood Culture AssayPAM2025-06-06
1980271770348255K243013LIAISON PLEX Gram-Negative Blood Culture AssayPEN2025-04-18
540931947463712K242613NxTAG® Respiratory Pathogen PanelOCC2024-10-02
1980271637468238K240627LIAISON PLEX Yeast Blood Culture AssayPEO2024-06-04
1980271602157710K233410LIAISON PLEX Respiratory Flex AssayQOF2024-03-01
540931727233441K231758NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)QOF2024-03-11
540931144124608K193167NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT SoftwareOCC2019-12-11
540921482390399K191742ARIES MRSA AssayNQX2019-09-25
540931923683921K191161xTAG Gastrointestinal Pathogen Panel (GPP)PCH2019-11-12
540931865319710K191160xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)PCH2019-11-04
540931609194887K183030xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)PCH2018-11-30
540931870390410K183023xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)PCH2018-11-30
540921282125103K172402ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File KitPGX2017-10-30
540921306059713K171441ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension KitOZN2017-07-21
540931506245622K170492xTAG CYP2D6 Kit v3NTI2017-08-11
540921090200204K163626ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File KitOZZ2017-05-02
540931042642641K163347xTAG Cystic Fibrosis 39 Kit v2NUA2016-12-15
540931489899718K163336xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTRNUA2016-12-15
540921436017410K162772ARIES GBS AssayNJR2016-12-23
540921837225659K161495ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)OOI2016-06-30
540921559271756K161220ARIES® Flu A/B & RSV AssayOCC2016-08-02
540921110078486K160517ARIES SystemOOI2016-04-12
540921680564076K152386NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT SoftwareOCC2015-12-17
540931680564076K152386NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT SoftwareOCC2015-12-17
540921796353557K151917ARIES SystemOOI2015-10-06
540921251880084K151906ARIES 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)PGI2015-10-06
540921001873961K143653Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)OCC2015-09-04
1980271001873961K143653Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)OCC2015-09-04
540931449927313K140647XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP)PCH2014-10-24
540931677106998K140377XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP)PCH2014-09-16
1980271261375500K140083VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)PCH2014-06-20
540921078796600K133302FLEXMAP 3DNSU2014-01-10
1980271445187207K132843VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)PEN2014-01-08
540931157960488K131565XTAG CYP2C19 KIT V3NTI2013-09-11
540931585803848K130189XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE)NTI2013-05-21
1980271401015531K123197VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)OZN2012-12-05
1980271806517616K122514VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TESTPAM2012-09-19
540921653495788K121894XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIXPCH2013-03-21
540931653495788K121894XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIXPCH2013-03-21
540922053700679K121399LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD PNSU2013-01-09
1980271394773478K120466VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)NTI2012-11-06
1980271508942374K112424VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)NQX2011-12-16
1980271870084637K103209VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)OCC2011-01-10
1399251924811666K100336MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711OQO2010-05-12
540931238965019K093420XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254)NTI2010-08-26
1980271059344464K093337VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEMOCC2009-11-17
1980271871551094K092957VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TESTOCC2009-10-21
1980271202698816K092566VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP)OCC2009-10-09
540931618704888K083846XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267NUA2009-09-01
540931548656302K083845XTAG CF60 KIT V2NUA2009-12-11
1980271905803285K083294VERIGENE CFTR NUCLEIC ACID TEST AND VERIGENE CFTR POLYT NUCLEIC ACID TESTNUA2009-07-24
1980271328652215K083088VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TESTOCC2009-05-01
540921086463388K073506LUMINEX LX 100/200 INSTRUMENTNSU2008-03-07
1980271616711135K070804VERIGENE SYSTEM, VERIGENE WARFARIN METABOLISM NUCLEIC ACID TESTODW2007-09-17
1980271557317753K070597VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TESTNSU2007-10-11
540932040700212DEN130003XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS)PCH2013-01-14
1980271211703124DEN120014VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)PAM2012-06-26
540931214056701DEN070013ID-TAG RESPIRATORY VIRAL PANELOCC2008-01-03
1399251038153214
1399251830074714
540921237064220
540931583147392

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OCC132024-10-02
PCH112026-05-19
NTI52017-08-11
NUA52016-12-15
NSU42014-01-10
PAM32025-06-06
OOI32016-06-30
PEN22025-04-18
QOF22024-03-11
NQX22019-09-25
OZN22017-07-21
PEO12024-06-04
PGX12017-10-30
OZZ12017-05-02
NJR12016-12-23
PGI12015-10-06
OQO12010-05-12
ODW12007-09-17

PMN#

41 records. Showing 1-40. Next

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

108 records. Showing 1-40. Next