Echovirus Negative Control

Basic Information

• Brand Name: Echovirus Negative Control
• Primary DI: B110ECN44100
• Version / Model: ECN-4410
• Catalog Number: ECN-4410
• Company Name: Bion Enterprises, Ltd.
• Labeler DUNS: 024824641
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 3
• Public Version Date: 2020-03-04
• Public Version Status: Update
• Public Device Record Key: 3a2adcaf-9435-4827-98f4-f2f5a8154e82
• Distribution End Date: 2017-01-30

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: Yes
• 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
GNI	Antisera, Neutralization, Echovirus 1-34	Microbiology	866.3205	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48552	Multiple enterovirus 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 one or multiple virus serotypes from within the enterovirus family, in a clinical specimen. Enteroviruses intended to be detected may include Coxsackie viruses subgroups A and B, polioviruses, echoviruses and/or enteroviruses type 68-71.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B110ECN44100	HIBCC

Customer Contacts

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

Storage Conditions

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