ARK™ Ketamine II Assay

Basic Information

• Brand Name: ARK™ Ketamine II Assay
• Primary DI: 00812101031599
• Version / Model: 5083-0001-00
• Catalog Number: 5083-0001-00
• Company Name: ARK DIAGNOSTICS INC
• Labeler DUNS: 164880598
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-27
• Public Version: 1
• Public Version Date: 2026-01-05
• Public Version Status: New
• Public Device Record Key: 0fede8f8-04ee-457d-a8ce-0bf1b18c4189

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LCM	Enzyme Immunoassay, Phencyclidine	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
62129	Ketamine/ketamine metabolite IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative detection of ketamine and/or ketamine metabolites in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812101031599	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius