ARK™ Ethyl Glucuronide Assay 5036-0004-01

GUDID 00858724003612

The ARK™ Ethyl Glucuronide Assay is intended for the qualitative and semiquantitative determination of ethyl glucuronide in human urine at cutoff concentrations of 500 ng/mL and 1000 ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting ethyl glucuronide in urine and is designated for professional use on automated clinical chemistry analyzers.

ARK DIAGNOSTICS INC

Ethyl glucuronide (EtG) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00858724003612
• NIH Device Record Key: 5b3314e5-780b-40ea-99ed-41c2fb9dbfe3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARK™ Ethyl Glucuronide Assay
• Version Model Number: 5036-0004-01
• Catalog Number: 5036-0004-01
• Company DUNS: 164880598
• Company Name: ARK DIAGNOSTICS INC
• 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: 5102706270
• Email: customersupport@ark-tdm.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858724003612 [Primary]

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-13
• Device Publish Date: 2018-07-12

On-Brand Devices [ ARK™ Ethyl Glucuronide Assay]

• 00858724003629: The ARK™ Ethyl Glucuronide Assay is intended for the qualitative and semiquantitative determi
• 00858724003612: The ARK™ Ethyl Glucuronide Assay is intended for the qualitative and semiquantitative determi
• 00858724003605: The ARK™ Ethyl Glucuronide Assay is intended for the qualitative and semiquantitative determi
• 00858724003469: The ARK™ Ethyl Glucuronide Assay is intended for the qualitative and semiquantitative determi