ClearanceBrief
Company · US

Luminex Corporation

FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2026. Name variants (Inc, Corp, punctuation) are merged.

18510(k) clearances (1 in 12 months)
41recalls (1 in 12 months)
35recalls that name a 510(k)

Product codes

CodeDeviceRecords
OOIReal Time Nucleic Acid Amplification System9
OCCRespiratory Virus Panel Nucleic Acid Assay System8
PAMGram-Positive Bacteria And Their Resistance Markers7
PCHGastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System6
NSUInstrumentation For Clinical Multiplex Test Systems5
OZNC. Difficile Toxin Gene Amplification Assay4
PENGram-Negative Bacteria And Associated Resistance Markers4
NJRNucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test2
OZZBordetella Pertussis Dna Assay System2
PGIHerpes Virus (Vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples2
PGXGroups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System2
QJRReagents, 2019-Novel Coronavirus Nucleic Acid2
NQXSystem, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen1
NTIDrug Metabolizing Enzyme Genotyping Systems1
OZEInfluenza A And Influenza B Multiplex Nucleic Acid Assay1
PEOFungal Organisms, Nucleic Acid-Based Assay1
PEPMolecular Erythrocyte Typing Test1
QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
May 19, 2026K253722LIAISON PLEX Gastrointestinal Flex Assay
Luminex Corporation
PCH
Jun 6, 2025K243490LIAISON PLEX Gram-Positive Blood Culture Assay
Luminex Corporation
PAM
Apr 18, 2025K243013LIAISON PLEX Gram-Negative Blood Culture Assay
Luminex Corporation
PEN
Jun 4, 2024K240627LIAISON PLEX Yeast Blood Culture Assay
Luminex Corporation
PEO
Mar 1, 2024K233410LIAISON PLEX Respiratory Flex Assay
Luminex Corporation
QOF
Sep 25, 2019K191742ARIES MRSA Assay
Luminex Corporation
NQX
Oct 30, 2017K172402ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit
Luminex Corporation
PGX
Jul 21, 2017K171441ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cass
Luminex Corporation
OZN
May 2, 2017K163626ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit
Luminex Corporation
OZZ
Dec 23, 2016K162772ARIES GBS Assay
Luminex Corporation
NJR
Aug 2, 2016K161220ARIES® Flu A/B & RSV Assay
Luminex Corporation
OCC
Jun 30, 2016K161495ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)
Luminex Corporation
OOI
Apr 12, 2016K160517ARIES System
Luminex Corporation
OOI
Oct 6, 2015K151917ARIES System
Luminex Corporation
OOI
Oct 6, 2015K151906ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cas
Luminex Corporation
PGI
Jan 10, 2014K133302FLEXMAP 3D
Luminex Corp.
NSU
Jan 9, 2013K121399LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P
Luminex Corp.
NSU
Mar 7, 2008K073506LUMINEX LX 100/200 INSTRUMENT
Luminex Corp., CA
NSU

Latest recalls

DateFirm and productCodeLinked 510(k)
Nov 5, 2026Luminex Corporation
LIAISON PLEX Gram-Negative Blood Culture Assay Catalog No. 20-005-303
Open, Classified		 NSUK243013
Jun 3, 2025Luminex Corporation
VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test
Completed		 PENK132843
Aug 8, 2024Luminex Corporation
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Open, Classified		 PAMK122514
Dec 6, 2023Luminex Corporation
Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 2
Open, Classified		 PAMK122514
Jun 28, 2023Luminex Corporation
VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
Open, Classified		 OZNK123197
Jun 28, 2023Luminex Corporation
Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
Open, Classified		 PCHK140083
Oct 26, 2022Luminex Corporation
ARIES SARS-CoV-2 Assay, REF: 50-10047
Open, Classified		 QJRNone listed
Jul 14, 2022Luminex Corporation
ARIES SARS-CoV-2 Assay
Open, Classified		 QJRNone listed
Jun 17, 2022Luminex Corporation
VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
Open, Classified		 PCHNone listed
Jun 17, 2022Luminex Corporation
Verigene CDF Nucleic Acid Test, Part No. 30-002-22
Open, Classified		 OZNNone listed
May 13, 2022Luminex Corporation
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Open, Classified		 OOIK143653
Feb 15, 2022Luminex Corporation
VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
Open, Classified		 PEPK132843
Nov 17, 2021Luminex Corporation
ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Terminated		 OOIK161495
Aug 3, 2021Luminex Corporation
Verigene EP Amplification Reagent Kit Test
Open, Classified		 PCHK140083
Apr 16, 2021Luminex Corporation
ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Terminated		 OOIK161495
Mar 18, 2021Luminex Corporation
VERIGENE Processor SP - Product Usage: intended for processing and identifying nucleic acids utilizing gold nanoparticle probe technology.
Open, Classified		 PCHK140083
Oct 30, 2020Luminex Corporation
Verigene Gram Negative Blood Culture Nucleic Acid Test v2 (BC-GNv2) Model Number: 20-006-026
Open, Classified		 OCCNone listed
Oct 30, 2020Luminex Corporation
Verigene Clostridium difficile Nucleic Acid Test Kit (CDF) Model Number: 20-006-022
Open, Classified		 OCCK123197
Oct 30, 2020Luminex Corporation
Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023
Open, Classified		 OCCK140083
Oct 30, 2020Luminex Corporation
Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) Model Number: 20-006-021
Open, Classified		 OCCK132843
Oct 30, 2020Luminex Corporation
Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) Model Number: 20-006-018
Open, Classified		 OCCK122514
Oct 30, 2020Luminex Corporation
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024
Open, Classified		 OCCK143653
Oct 13, 2020Luminex Corporation
Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: IVD sample processor, whi
Terminated		 PENK143653
Oct 13, 2020Luminex Corporation
Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: IVD sample processor, whi
Terminated		 PAMK143653
Jun 15, 2020Luminex Corporation
Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Ver
Terminated		 PENK132843
Jun 15, 2020Luminex Corporation
Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Ver
Terminated		 PAMK122514
Aug 19, 2019Luminex Corporation
Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017
Terminated		 OOIK151917
K160517 +2
Aug 15, 2019Luminex Corporation
ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073
Open, Classified		 OOIK160517
Aug 15, 2019Luminex Corporation
ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
Open, Classified		 OZNK171441
Aug 15, 2019Luminex Corporation
ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469
Open, Classified		 PGXK172402
Aug 15, 2019Luminex Corporation
ARIES GBS Assay , REF 50-10021, UDI # 00840487100165
Open, Classified		 NJRK162772
Aug 15, 2019Luminex Corporation
ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158
Open, Classified		 OZEK161220
Aug 15, 2019Luminex Corporation
ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
Open, Classified		 PGIK151906
K161495
Aug 15, 2019Luminex Corporation
Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452
Open, Classified		 OZZK163626
Apr 22, 2019Luminex Corporation
Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
Open, Classified		 NSUNone listed
Feb 11, 2019Luminex Corporation
Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene System is a qualitative, m
Terminated		 PAMK122514
Dec 10, 2018Luminex Corporation
VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
Open, Classified		 OCCK143653
Nov 10, 2018Luminex Corporation
VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simultaneous detection and identification of potentially patho
Terminated		 PAMK122514
May 8, 2018Luminex Corporation
Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-B
Terminated		 PCHK142033
Apr 19, 2017Luminex Corporation
ARIES System and ARIES M1 System
Terminated		 OOIK151917
K160517 +1
Aug 31, 2011Luminex Corporation
xTAG CYP2D6 Kit v3 IVD For use with Luminex 100/200 Instrument Luminex Molecular Diagnostics, Inc. 439 University Ave. Toronto, Ontario Canada Catalog # I030B0373 The xTAG CYP2D6 Kit v3 is a device
Terminated		 NTIK093420
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