MarDx 40-8696M

GUDID 05391516746632

Borrelia burgdorferi EIA IgM

CLARK LABORATORIES, INC.

Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 05391516746632
• NIH Device Record Key: b46455f9-89b8-4284-a02e-97a5d67a4be4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MarDx
• Version Model Number: 40-8696M
• Catalog Number: 40-8696M
• Company DUNS: 623214079
• Company Name: CLARK 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-325-3424
• Email: Customerservice@trinityusa.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	05391516746632 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894293

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: 4
• Public Version Date: 2019-11-06
• Device Publish Date: 2017-05-07

On-Brand Devices [MarDx]

• 05391516746649: Borrelia burgdorferi EIA IgM
• 05391516746632: Borrelia burgdorferi EIA IgM
• 05391516746618: Borrelia burgdorferi EIA IgG + IgM
• 05391516746601: Borrelia burgdorferi EIA IgG + IgM
• 05391516746625: Borrelia burgdorferi EIA IgG