Coxsackie B1-6 Screen Virus Antigen Substrate, 12 wells, For IFA Test System CB-3312

GUDID B110CB33120

Bion Enterprises, Ltd.

Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent

• Primary Device ID: B110CB33120
• NIH Device Record Key: 7d07376b-6bae-4853-b4fe-0a5ce1698c14
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coxsackie B1-6 Screen Virus Antigen Substrate, 12 wells, For IFA Test System
• Version Model Number: CB-3312
• Catalog Number: CB-3312
• Company DUNS: 024824641
• Company Name: Bion Enterprises, Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com
• Phone: 847-544-5044
• Email: bion@mblintl.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B110CB33120 [Primary]

FDA Product Code

• GNN: Antisera, Neutralization, Coxsackievirus A 1-24, B 1-6

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-04
• Device Publish Date: 2016-09-12

Devices Manufactured by Bion Enterprises, Ltd.

• B110BBM61300 - Borrelia IgM Control: 2020-04-09
• B110RGM7612D0 - BP 180 ELISA TEST: 2020-04-09
• B110ACA10430 - ANA ACA Control: 2020-03-04
• B110AD31120 - Adenovirus Antigen Substrate, 12 wells, For IFA Test System: 2020-03-04
• B110ADG31200 - Adenovirus IgG Control: 2020-03-04
• B110ADN31100 - Adenovirus Negative Control: 2020-03-04
• B110AN10060 - Antinuclear Antibody HEp-2 Antigen Substrate 6 wells, For IFA Test System: 2020-03-04
• B110AN10120 - Antinuclear Antibody HEp-2 Antigen Substrate, 12 wells, For IFA Test System: 2020-03-04