ARK™ Hydrocodone Calibrator

Basic Information

• Brand Name: ARK™ Hydrocodone Calibrator
• Primary DI: 00812101031094
• Version / Model: 5076-0002-00
• Catalog Number: 5076-0002-00
• Company Name: ARK DIAGNOSTICS INC
• Labeler DUNS: 164880598
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-16
• Public Version: 1
• Public Version Date: 2024-10-24
• Public Version Status: New
• Public Device Record Key: 1c86b4c4-3bef-4c67-9ec8-7bb2f54ac349

Device Description

The ARK™ Hydrocodone Calibrator is intended for use in calibration of the ARK™ Hydrocodone Assay.

Device Characteristics

• Single Use: No
• 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
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	862.3650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62961	Pethidine IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of pethidine, also known as meperidine (e.g., Demerol), in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812101031094	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K231752	000

Storage Conditions

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