C6 B. burgdorferi (Lyme) ELISA

GUDID 00863782000305

IMMUNETICS, INC.

Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00863782000305
• NIH Device Record Key: d422e6b9-ceec-436b-9ecc-57ef3e3b8f95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C6 B. burgdorferi (Lyme) ELISA
• Version Model Number: DK-E352-096
• Company DUNS: 174347732
• Company Name: IMMUNETICS, 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863782000305 [Primary]

FDA Product Code

• LSR: Reagent, Borrelia Serological Reagent

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-11-15