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 Multiple drugs of abuse IVD, kit, multiplex Multiple drugs of abuse IVD, kit, multiplex Multiple drugs of abuse IVD, kit, multiplex Multiple drugs of abuse IVD, kit, multiplex Multiple drugs of abuse IVD, kit, multiplex Multiple drugs of abuse IVD, kit, multiplex Multiple drugs of abuse IVD, kit, multiplex Multiple drugs of abuse IVD, kit, multiplex Multiple drugs of abuse IVD, kit, multiplex Multiple drugs of abuse IVD, kit, multiplex Multiple drugs of abuse IVD, kit, multiplex Multiple drugs of abuse IVD, kit, multiplex Multiple drugs of abuse IVD, kit, multiplex Multiple drugs of abuse IVD, kit, multiplex 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