FDA.reportPublic FDA data

ARIES® MRSA Assay

Primary DI
00840487101445
Brand
ARIES® MRSA Assay
Company
LUMINEX CORPORATION
Model
50-10034
Device description
The ARIES® MRSA Assay is an integrated real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of methicillin–resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization
Published
2019-10-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NQXSYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQXSystem, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct SpecimenMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191742000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191742000ARIES MRSA AssayLuminex Corporation2019-09-25NQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840487101445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840487101445008404871014458404871014450840487101445

GMDN Terms#

Term, Definition table
TermDefinition
MRSA nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid conferring methicillin resistance, in methicillin-resistant Staphylococcus aureus (MRSA) bacteria present in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(512)381-4397support@luminexcorp.com

Regulatory Flags#

DUNS number
965476641
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840487101513Hypercoagulation Panel (HC) Nucleic Acid Test Cartridge20-006-00120-006-0012019-12-05
00840487101728Hypercoagulation Panel (HC) Sample Buffer30-001-00130-001-0012019-12-05
00840487101858LIAISON PLEX Gram-Positive Blood Culture Assay20-005-30520-005-3052025-07-11
00840487101865LIAISON PLEX Yeast Blood Culture Assay Kit20-005-30620-005-3062024-10-22
00840487101940LIAISON PLEX® Respiratory Flex Assay Kit20-005-32220-005-3222024-06-20
00840487101841LIAISON PLEX Gram-Negative Blood Culture Assay20-005-30320-005-3032025-06-11
00840487100127MHV Control Primers 5380638062016-12-16
00840487100233MultiCode® Chlamydophila pneumoniae Primers392539252016-12-16
00840487100240MultiCode® Legionella pneumophila Primers392639262016-12-16
00840487100257MultiCode® Mycoplasma pneumoniae Primers392739272016-12-16
00840487101049MHV DNA Sample Processing Control370037002016-12-16
00840487101056MHV DNA Sample Processing Control3700-023700-022016-12-16
00840487101063MHV DNA Sample Processing Control3700-213700-212016-12-16
00840487101070MHV DNA Sample Processing Control3700-223700-222016-12-16
00840487101087MHV DNA Sample Processing Control371037102016-12-16
00840487101100MHV DNA Amplification Control369436942016-12-16
00840487101155MHV Control Primers 1380238022016-12-16
00840487101179MHV Control Primers 2380338032016-12-16
00840487101186MHV Control Primers 23803-213803-212016-12-16
00840487101193MHV Control Primers 3380438042016-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840487101575Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test CartridgeLUMINEX CORPORATIONNQX2019-12-05
00840487101629Gram-Positive Blood Culture (BC-GP) Extraction TrayLUMINEX CORPORATIONNQX2019-12-05
00840487101674Gram-Positive Blood Culture (BC-GP) Utility TrayLUMINEX CORPORATIONNQX2019-12-05
07332940000141Xpert MRSA/SA Blood CultureCEPHEIDNQX2018-01-29
07332940000158Xpert SA Nasal CompleteCEPHEIDNQX2018-01-29
07332940000165Xpert SA Nasal CompleteCEPHEIDNQX2018-01-29
07332940000189Xpert MRSA/SA SSTICEPHEIDNQX2018-01-29
07332940000196Xpert MRSACEPHEIDNQX2018-01-29
07332940001711Xpert MRSA NxGCEPHEIDNQX2018-01-29
07332940001728Xpert MRSA NxGCEPHEIDNQX2018-01-29
07332940002442Xpert MRSACEPHEIDNQX2018-01-29
00382904434199BD MAX™ StaphSRBECTON, DICKINSON AND COMPANYNQX2017-04-12
00382904434618BD MAX™ MRSA XTBECTON, DICKINSON AND COMPANYNQX2017-04-12
03661540950001MRSA/SA ELITe MGBElitechgroup Mdx LLCNQX2016-10-13
00857573006119Gram-Positive Blood Culture (BC-GP) Nucleic Acid Test CartridgeNANOSPHERE, INC.NQX2016-09-23
00857573006218Gram-Positive Blood Culture (BC-GP) Extraction TrayNANOSPHERE, INC.NQX2016-09-23
00857573006287Gram-Positive Blood Culture (BC-GP) Utility TrayNANOSPHERE, INC.NQX2016-09-23
00382904414481BD GeneOhm™ StaphSR assay 48 TestsAGeneohm Sciences Canada IncNQX2016-08-10
00382904416386BD GeneOhm™ MRSA ACP Lysis KitGeneohm Sciences Canada IncNQX2016-08-10
00382904416379BD GeneOhm™ MRSA ACP Assay (48 tests)Geneohm Sciences Canada IncNQX2016-08-09
00382904416393BD GeneOhm™ MRSA ACP AssayGeneohm Sciences Canada IncNQX2016-08-09
00382904429539BD MAX™ MRSAGeneohm Sciences Canada IncNQX2016-07-27
00382904419165BD MAX™ SystemBECTON, DICKINSON AND COMPANYNQX2016-05-19
00875197002973LightCycler® MRSA Advanced TestRoche Molecular Systems, Inc.NQX2016-03-31
00875197002997LightCycler® Advanced LysisRoche Molecular Systems, Inc.NQX2016-03-31
00875197004410cobas® MRSA/SA TestRoche Molecular Systems, Inc.NQX2016-03-31
00875197004427cobas® MRSA/SA TestRoche Molecular Systems, Inc.NQX2016-03-31
00875197004441cobas® MRSA/SA Controls and Cofactor KitRoche Molecular Systems, Inc.NQX2016-03-31