CRP CAL CP2499

GUDID 05055273201727

The device is intended for in vitro diagnostic use in the calibration of CRP assays on clinical chemistry systems.

RANDOX LABORATORIES LIMITED

C-reactive protein (CRP) IVD, calibrator

• Primary Device ID: 05055273201727
• NIH Device Record Key: 68533975-7cf9-4632-abfa-4aeee3185c83
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CRP CAL
• Version Model Number: CP2499
• Catalog Number: CP2499
• 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
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com
• Phone: +442894451070
• Email: technical.services@randox.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273201727 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022682

FDA Product Code

• JIS: Calibrator, Primary

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 [CRP CAL]

• 05055273201727: The device is intended for in vitro diagnostic use in the calibration of CRP assays on clinical
• 05055273201697: The device is intended for in vitro diagnostic use in the calibration of CRP assays on clinical
• 05055273201659: The device is intended for in vitro diagnostic use in the calibration of CRP assays on clinical