DOA CAL EV3550

GUDID 05055273202458

Evidence® Drugs of Abuse Calibrators are intended for in vitro diagnostic use in the calibration of the Randox Drugs of Abuse Panel on the Evidence® a

RANDOX LABORATORIES LIMITED

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• Primary Device ID: 05055273202458
• NIH Device Record Key: f7e46e86-0913-4409-beea-f68a3d8d8fb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DOA CAL
• Version Model Number: EV3550
• Catalog Number: EV3550
• 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: +442894422413
• Email: technical.services@randox.com
• Phone: +442894422413
• Email: technical.services@randox.com
• Phone: +442894422413
• Email: technical.services@randox.com
• Phone: +442894422413
• Email: technical.services@randox.com
• Phone: +442894422413
• Email: technical.services@randox.com
• Phone: +442894422413
• Email: technical.services@randox.com
• Phone: +442894422413
• Email: technical.services@randox.com
• Phone: +442894422413
• Email: technical.services@randox.com
• Phone: +442894422413
• Email: technical.services@randox.com
• Phone: +442894422413
• Email: technical.services@randox.com
• Phone: +442894422413
• Email: technical.services@randox.com
• Phone: +442894422413
• Email: technical.services@randox.com
• Phone: +442894422413
• Email: technical.services@randox.com
• Phone: +442894422413
• Email: technical.services@randox.com
• Phone: +442894422413
• Email: technical.services@randox.com
• Phone: +442894422413
• 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
• 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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055273202458 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030360

FDA Product Code

• DKB: Calibrators, Drug Mixture

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

On-Brand Devices [DOA CAL]

• 05055273207880: The Randox Multidrug Calibrator Set is intended for use in the calibration of Methamphetamine, B
• 05055273202458: Evidence® Drugs of Abuse Calibrators are intended for in vitro diagnostic use in the calibratio