ARK™ Ethyl Glucuronide Negative Calibrator 5036-0005-01

GUDID 00858724003643

ARK™ Ethyl Glucuronide Negative Calibrator is intended for use in calibration of the ARK Ethyl Glucuronide Assay.

ARK DIAGNOSTICS INC

Ethyl glucuronide (EtG) IVD, calibrator

• Primary Device ID: 00858724003643
• NIH Device Record Key: e1e2917d-6285-4ec9-a496-3da702e36315
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARK™ Ethyl Glucuronide Negative Calibrator
• Version Model Number: 5036-0005-01
• Catalog Number: 5036-0005-01
• 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	00858724003643 [Primary]

FDA Product Code

• DLJ: Calibrators, Drug Specific

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 Negative Calibrator]

• 00858724003643: ARK™ Ethyl Glucuronide Negative Calibrator is intended for use in calibration of the ARK Ethyl
• 00858724003513: ARK™ Ethyl Glucuronide Negative Calibrator is intended for use in calibration of the ARK Ethyl