RABS RP8398

GUDID 05055273214307

The Reagent Precision Test is used on the RX series clinical chemistry systems for checking proper functioning of the reagent fluid metering and photo

RANDOX LABORATORIES LIMITED

Optical instrument calibration/verification solution IVD

• Primary Device ID: 05055273214307
• NIH Device Record Key: f2d15d2b-ed4b-445a-8d60-6eff824b5a88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RABS
• Version Model Number: RP8398
• Catalog Number: RP8398
• 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: +44289445170
• Email: technical.services@randox.com
• Phone: +44289445170
• Email: technical.services@randox.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stable on board the analyser for 30 days at approximately 10°C.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Stable on board the analyser for 30 days at approximately 10°C.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273214307 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131554

FDA Product Code

• JJE: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

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: 2018-11-08
• Device Publish Date: 2016-09-26

On-Brand Devices [RABS]

• 05055273214307: The Reagent Precision Test is used on the RX series clinical chemistry systems for checking prop
• 05055273205091: The Reagent Precision Test is used on the RX series clinical chemistry systems for checking prop