ARK™ Ketamine II Assay 5083-0001-02

GUDID 00812101031612

The ARK Ketamine II Assay is an immunoassay intended for the qualitative detection and/or semi-quantitative estimation of ketamine in human urine at cutoffs of 50 ng/mL and 100 ng/mL.

ARK DIAGNOSTICS INC

Ketamine/ketamine metabolite IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00812101031612
• NIH Device Record Key: 034d2a3b-8fbb-4f6e-85b0-bdc4e8319970
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARK™ Ketamine II Assay
• Version Model Number: 5083-0001-02
• Catalog Number: 5083-0001-02
• 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
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.com
• Phone: 5102706270
• Email: customersupport@ark-tdm.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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812101031612 [Primary]

FDA Product Code

• LCM: Enzyme Immunoassay, Phencyclidine

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: 2026-01-05
• Device Publish Date: 2025-12-27

On-Brand Devices [ARK™ Ketamine II Assay]

• 00812101031995: The ARK Ketamine II Assay is an immunoassay intended for the qualitative detection and/or semi-q
• 00812101031612: The ARK Ketamine II Assay is an immunoassay intended for the qualitative detection and/or semi-q
• 00812101031605: The ARK Ketamine II Assay is an immunoassay intended for the qualitative detection and/or semi-q
• 00812101031599: The ARK Ketamine II Assay is an immunoassay intended for the qualitative detection and/or semi-q