ImmunoWELL Borrelia (Lyme) 3110

GUDID 00613745031101

The ImmunoWELL Borrelia (Lyme) Test is an enzyme immunoassay (EIA) for the qualitative and/or semi-quantitative detection of Borrelia burgdorferi total antibodies (IgG, IgM, and IgA) in serum and is used as an aid in the diagnosis of Lyme disease.

Genbio

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

• Primary Device ID: 00613745031101
• NIH Device Record Key: c097f5cb-a7ee-4547-aaad-72434e9e8eb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ImmunoWELL Borrelia (Lyme)
• Version Model Number: 800-3110
• Catalog Number: 3110
• Company DUNS: 940425333
• Company Name: Genbio
• 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: true
• 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: 858-592-9300
• Email: support@genbio.com
• Phone: 858-592-9300
• Email: support@genbio.com
• Phone: 858-592-9300
• Email: support@genbio.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613745031101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K911590

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

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• 00613745010069 - ImmunoFA 10x PBS: 2018-07-06 10-fold concentrate of 0.01M PBS
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• 00613745012018 - ImmunoFA Toxoplasma Slides: 2018-07-06 Toxoplasma Slides for use with ImmunoFA Toxoplasma kits