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BD GeneOhm™ VanR Assay

Primary DI
00382904416652
Brand
BD GeneOhm™ VanR Assay
Company
Geneohm Sciences Canada Inc
Model
441665
Catalog number
441665
Device description
BD GeneOhm™ VanR Assay 200 Tests
Published
2016-05-19
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
NIJSYSTEM, TEST, GENOTYPIC DETECTION, RESISTANT MARKERS, ENTEROCOCCUS SPECIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NIJSystem, Test, Genotypic Detection, Resistant Markers, Enterococcus SpeciesMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904416652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904416652003829044166523829044166520382904416652

GMDN Terms#

Term, Definition table
TermDefinition
Vancomycin-resistant Enterococcus (VRE) 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 conferring vancomycin resistance in, vancomycin-resistant Enterococcus (VRE) bacteria present in a clinical specimen, 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
00382904429539BD MAX™ MRSA4429534429532016-07-27
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
07332940000233Xpert vanACEPHEIDNIJ2018-01-29