RF RF7980

GUDID 05055273205077

The product is a latex agglutination slide test for the qualitative and semi quantitative in vitro determination of Rheumatoid Factor in serum.

RANDOX LABORATORIES LIMITED

Rheumatoid factor IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 05055273205077
• NIH Device Record Key: 9dee85e0-07eb-462f-a05a-a29620de592e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RF
• Version Model Number: RF7980
• Catalog Number: RF7980
• Company DUNS: 227530649
• Company Name: RANDOX LABORATORIES LIMITED
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +442894451070
• 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	05055273205077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972220

FDA Product Code

• DHR: System, Test, Rheumatoid Factor

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: 2016-09-16

On-Brand Devices [RF]

• 05055273205084: The product is a latex agglutination slide test for the qualitative and semi quantitative in vit
• 05055273205077: The product is a latex agglutination slide test for the qualitative and semi quantitative in vit
• 05055273205060: A RF test system is a device intended for the quantitative in vitro determination of Rheumatoid
• 05055273205053: This product is intended for us as a latex enhanced immunoturbidimetric test for the quantitativ
• 05055273205046: The product is a latex agglutination slide test for the qualitative and semi quantitative in vit
• 05055273205022: Latex agglutination slide test for the qualitative and semi quantitative in vitro determination