FDA.reportPublic FDA data

BD MAX™ MRSA

Primary DI
00382904429539
Brand
BD MAX™ MRSA
Company
Geneohm Sciences Canada Inc
Model
442953
Catalog number
442953
Device description
BD MAX™ MRSA
Published
2016-07-27
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
K120138000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120138000BD MAX MRSA ASSAY, BD MAX INSTRUMENTBd Diagnostics (Geneohm Sciences Canada, Inc)2012-07-05NQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904429539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904429539003829044295393829044295390382904429539

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 Temperature2 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)638-8663Technical_services@bd.com

Regulatory Flags#

DUNS number
255438483
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382904433789BD MAX™ Enteric Bacterial Panel (US/CAN)4433784433782016-07-27
00382904375065BD MAX™ RNA-34375064375062018-05-25
00382904416652BD GeneOhm™ VanR Assay4416654416652016-05-19
00382904433802BD MAX™ Enteric Parasite Panel (US/CAN)4433804433802016-05-19
00382904414481BD GeneOhm™ StaphSR assay 48 TestsA4414484414482016-08-10
00382904416379BD GeneOhm™ MRSA ACP Assay (48 tests)4416374416372016-08-09
00382904416386BD GeneOhm™ MRSA ACP Lysis Kit4416384416382016-08-10
00382904416393BD GeneOhm™ MRSA ACP Assay4416394416392016-08-09
00382904438241BD MAX™ CT/GC/TV4438244438242016-10-17

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
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
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