FDA.reportPublic FDA data

MRSA/SA ELITe MGB

Primary DI
03661540950001
Brand
MRSA/SA ELITe MGB
Company
Elitechgroup Mdx LLC
Model
M800346
Device description
MRSA/SA ELITe MGB™ is a qualitative in vitro diagnostic test for the direct detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA purified from nasal swabs. MRSA/SA ELITe MGB™ is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections or to guide or monitor treatment for MRSA infections. A negative result does not preclude MRSA/SA nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.
Published
2016-10-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K112937000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112937000MRSA/SA ELITE MGBElitech2012-06-01NQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661540950001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661540950001036615409500013661540950001

GMDN Terms#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8004532725mdx@elitechgroup.com

Regulatory Flags#

DUNS number
117458512
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661540953149DSQ Alert® HT Pneumocystis jirovecii Primer Mix M800849M8008492026-05-12
03661540953156DSQ Alert® HT Pneumocystis jirovecii Probe MixM800850M8008502026-05-12
03661540953118DSQ Alert Measles Primer Mix ASR, 48 rxnM800845M8008452026-03-24
03661540953125DSQ Alert Measles Probe Mix ASR, 48 rxnM800846M8008462026-03-24
03661540953132DSQ Alert RNase P Primer Mix ASR 48 rxnM800847M8008472026-03-24
03661540953163DSQ Alert RNase P Probe Mix ASR 48 rxnM800848M8008482026-03-24
03661540952722DSQ Alert HHV7 Primer Mix ASRM800766M8007662025-10-14
03661540952739DSQ Alert HHV7 Probe Mix ASRM800767M8007672025-10-14
03661540951411MGB Alert Internal Control Set IC2-480 rxn8003628003622020-09-15
03661540951862MGB Alert®Internal Control 1C Set, 480 rxn8003618003612020-09-15
03661540951336MGB Alert HHV-6 Primer Mix ASR - 480 rxn8003388003382020-09-14
03661540951770MGB Alert® Chlamydophila Pneumoniae Probe Mix ASR - 48 Reactions8004348004342020-09-08
03661540952906MGB Alert® HDV Primer Mix ASRM800817M8008172025-10-15
03661540952913MGB Alert HDV Probe Mix ASRM800818M8008182025-10-15
03661540952517MGB Alert 2X ELITaq Master Mix, 48rxnM800809M8008092023-02-03
03661540952524MGB Alert ELITaq Master Mix, 480 rxnM800810M8008102023-02-03
03661540950278MGB Alert Platinum Master Mix-48 rxnM800599M8005992020-09-15
03661540951725MGB Alert 2X PCR Master Mix 480 rxnM800547M8005472020-09-15
03661540951756MGB Alert One-Step Reverse Transcriptase PCR Master Mix M800689M8006892020-09-15
03661540951787MGB Alert 2X PCR Master Mix 48 rxnM800331M8003312020-09-15

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
00840487101445ARIES® MRSA AssayLUMINEX CORPORATIONNQX2019-10-08
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
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