SEROLOGY LYME DISEASE NEGATIVE CONTROL (LYME CONTROL -) SR10345

GUDID 05055273216387

Lyme Disease Negative Control is intended for use as an unassayed non-reactive quality assurance reagent, with in vitro assays detecting IgG antibodies to Borrelia burgdorferi and IgM antibodies to Borrelia burgdorferi.

RANDOX LABORATORIES LIMITED

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

• Primary Device ID: 05055273216387
• NIH Device Record Key: 3f210e40-4310-4ca4-9c38-4209aa494162
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SEROLOGY LYME DISEASE NEGATIVE CONTROL (LYME CONTROL -)
• Version Model Number: SR10345
• Catalog Number: SR10345
• 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	05055273216387 [Primary]

FDA Product Code

• MJY: Kit, Serological, Negative 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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