ARK™ EDDP Assay - 500mL 5051-0001-02

GUDID 00858724003865

The ARK™ EDDP Assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semi-quantitative determination of EDDP in human urine at cutoff concentrations of 100ng/mL and 300ng/mL. The assay provides a simple and rapid analytical screening procedure for detecting EDDP in urine on automated clinical chemistry analyzers.

ARK DIAGNOSTICS INC

2-ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) IVD, reagent

• Primary Device ID: 00858724003865
• NIH Device Record Key: c6340366-7f2b-4881-9a62-10ea8846a4b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARK™ EDDP Assay - 500mL
• Version Model Number: 5051-0001-02
• Catalog Number: 5051-0001-02
• 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	00858724003865 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182779

FDA Product Code

• DJR: Enzyme Immunoassay, Methadone

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: 2019-02-21
• Device Publish Date: 2019-01-21

Devices Manufactured by ARK DIAGNOSTICS INC

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• 00812101031629 - ARK™ Ketamine II Calibrator: 2026-01-05 The ARK Ketamine II Calibrator is intended for use in calibration of the ARK Ketamine II Assay.
• 00812101031636 - ARK™ Ketamine II Calibrator (Negative): 2026-01-05 The ARK Ketamine II Calibrator is intended for use in calibration of the ARK Ketamine II Assay.
• 00812101031643 - ARK™ Ketamine II Calibrator (50 ng/mL Cutoff): 2026-01-05 The ARK Ketamine II Calibrator is intended for use in calibration of the ARK Ketamine II Assay.
• 00812101031650 - ARK™ Ketamine II Calibrator (100 ng/mL Cutoff): 2026-01-05 The ARK Ketamine II Calibrator is intended for use in calibration of the ARK Ketamine II Assay.
• 00812101031667 - ARK™ Ketamine II Control (25/75): 2026-01-05 The ARK Ketamine II Control is intended for use in quality control of the ARK Ketamine II Assay.