CREA CR8316

GUDID 05055273208634

The is intended for the quantitative in vitro diagnostic determination of Creatinine in serum, plasma or urine

RANDOX LABORATORIES LIMITED

Creatinine IVD, reagent

• Primary Device ID: 05055273208634
• NIH Device Record Key: cee7bf8a-9faa-4124-be48-ae3c31dca380
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CREA
• Version Model Number: CR8316
• Catalog Number: CR8316
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Once opened and capped stable for 21 days when stored at 2-8°C
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273208634 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973993

FDA Product Code

• CGX: Alkaline Picrate, Colorimetry, Creatinine

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 [CREA]

• 05055273208634: The is intended for the quantitative in vitro diagnostic determination of Creatinine in serum, p
• 05055273201932: The is intended for the quantitative in vitro diagnostic determination of Creatinine in serum, p
• 05055273201918: The device intended for the quantitative in vitro determination of Creatinine in serum, plasma o
• 05055273201895: The is intended for the quantitative in vitro diagnostic determination of Creatinine in serum, p
• 05055273201888: The CREA method used on the Dimension clinical chemistry system is an in vitro diagnostic device