SEROLOGY LYME DISEASE POSITIVE CONTROL (LYME CONTROL +) SR10346

GUDID 05055273216394

Lyme Disease Positive Control is intended for use with in vitro assays, for determination of IgG antibodies to Borrelia burgdorferi and IgM antibodies to Borrelia burgdorferi. Lyme Disease Positive Control is unassayed without target values and is suitable for use on many analysers.

RANDOX LABORATORIES LIMITED

Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, control

• Primary Device ID: 05055273216394
• NIH Device Record Key: 271c9611-9d05-4bc5-9e0d-c2866cda1510
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SEROLOGY LYME DISEASE POSITIVE CONTROL (LYME CONTROL +)
• Version Model Number: SR10346
• Catalog Number: SR10346
• Company DUNS: 227530649
• Company Name: RANDOX LABORATORIES LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +442894422413
• Email: technical.services@randox.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273216394 [Primary]

FDA Product Code

• MJX: Kit, Serological, Positive Control

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: 2020-01-30
• Device Publish Date: 2020-01-22

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