BP 180 ELISA TEST RG-M7612-D

GUDID B110RGM7612D0

Bion Enterprises, Ltd.

Bullous pemphigoid antigen 2 (BPAG2) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: B110RGM7612D0
• NIH Device Record Key: 51c710df-0bdb-4fbc-a41c-4e1036af0cda
• Commercial Distribution Discontinuation: 2020-04-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BP 180 ELISA TEST
• Version Model Number: RG-M7612-D
• Catalog Number: RG-M7612-D
• 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: true
• Device Combination Product: false
• Single Use: false
• 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 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B110RGM7612D0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071961

FDA Product Code

• OEG: Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-04-09
• Device Publish Date: 2016-09-12

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