BD GeneOhm™ VanR Assay

Basic Information

• Brand Name: BD GeneOhm™ VanR Assay
• Primary DI: 00382904416652
• Version / Model: 441665
• Catalog Number: 441665
• Company Name: Geneohm Sciences Canada Inc
• Labeler DUNS: 255438483
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-19
• Public Version: 3
• Public Version Date: 2022-06-09
• Public Version Status: Update
• Public Device Record Key: 0cad21b3-41c4-49e6-be1f-d35dcf7387f9
• Distribution End Date: 2018-01-12

Device Description

BD GeneOhm™ VanR Assay 200 Tests

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NIJ	SYSTEM, TEST, GENOTYPIC DETECTION, RESISTANT MARKERS, ENTEROCOCCUS SPECIES	Microbiology	866.1640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
50903	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).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00382904416652	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius