EBV Negative Control

Basic Information

• Brand Name: EBV Negative Control
• Primary DI: B110EBN50100
• Version / Model: EBN-5010
• Catalog Number: EBN-5010
• Company Name: Bion Enterprises, Ltd.
• Labeler DUNS: 024824641
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 5
• Public Version Date: 2020-03-04
• Public Version Status: Update
• Public Device Record Key: 17e57ea6-3f14-4c49-bc0d-9e4913504ba9

Device Characteristics

• Single Use: No
• 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
LJN	Antibody Igm, If, Epstein-Barr Virus	Microbiology	866.3235	1

GMDN Terms

Code	Name	Definition	Implantable	Status
49680	Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to the Epstein-Barr virus nuclear antigen (EBNA) of Epstein-Barr virus (EBV) in a clinical specimen.	No	Obsolete
49666	Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to Epstein-Barr virus (EBV) in a clinical specimen.	No	Active
49660	Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Epstein-Barr virus (EBV) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B110EBN50100	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K893240	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius