Antinuclear Antibody HEp-2 Antigen Substrate, 12 wells, For IFA Test System AN-1012

GUDID B110AN10120

Bion Enterprises, Ltd.

Multiple antinuclear antibody (ANA) screening IVD, reagent

• Primary Device ID: B110AN10120
• NIH Device Record Key: 286489a9-9255-4df8-a581-e37ad00c4bf2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Antinuclear Antibody HEp-2 Antigen Substrate, 12 wells, For IFA Test System
• Version Model Number: AN-1012
• Catalog Number: AN-1012
• Company DUNS: 024824641
• Company Name: Bion Enterprises, Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B110AN10120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K872845

FDA Product Code

• DHN: Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-04
• Device Publish Date: 2016-09-12

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• B110AN10120 - Antinuclear Antibody HEp-2 Antigen Substrate, 12 wells, For IFA Test System: 2020-03-04