DOA EV3500

GUDID 05055273202137

The Evidence® Drugs of Abuse (DOA) Assays are in-vitro diagnostic tests for the qualitative determination of the parent molecule and metabolites of dr

RANDOX LABORATORIES LIMITED

Multiple drugs of abuse IVD, kit, multiplex

• Primary Device ID: 05055273202137
• NIH Device Record Key: 0ca14a85-7068-45a7-abb5-fc5e4c930bbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DOA
• Version Model Number: EV3500
• Catalog Number: EV3500
• 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	05055273202137 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030360

FDA Product Code

• LCM: Enzyme Immunoassay, Phencyclidine

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]

• 05055273202397: The Evidence® Drugs of Abuse (DOA) Assays are in-vitro diagnostic tests for the qualitative det
• 05055273202137: The Evidence® Drugs of Abuse (DOA) Assays are in-vitro diagnostic tests for the qualitative det