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Luminex Corporation

Matched from indexed company URL: LUMINEX CORP.

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
00840487101414MHV 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.+1(866)327-3290support@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
00840487101742Multicode® 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+1(866)327-3290support@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

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#

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

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

80 records. Showing 1-40. Next