Bio-Rad Laboratories 25185

GUDID 00847865010801

EB VCA IgM EIA

Bio-RAD Laboratories, Inc.

Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00847865010801
• NIH Device Record Key: b7882a9b-aa32-4fb3-a3bc-1ebe5faef35b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bio-Rad Laboratories
• Version Model Number: 25185
• Catalog Number: 25185
• Company DUNS: 844766394
• Company Name: Bio-RAD Laboratories, Inc.
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847865010801 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033780

FDA Product Code

• LJN: ANTIBODY IGM, IF, EPSTEIN-BARR VIRUS

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-01-12
• Device Publish Date: 2023-01-04

On-Brand Devices [Bio-Rad Laboratories]

• 00847865010801: EB VCA IgM EIA
• 00847865010795: EB VCA IgG EIA
• 00847865010788: EB NA IgG EIA
• 00847865010771: Mumps IgG EIA