ARK™ Pregabalin Urine Calibrator

Basic Information

• Brand Name: ARK™ Pregabalin Urine Calibrator
• Primary DI: 00858724003292
• Version / Model: 5035-0002-00
• Catalog Number: 5035-0002-00
• Company Name: ARK DIAGNOSTICS INC
• Labeler DUNS: 164880598
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: ce484425-c136-4f64-8e02-926184bf3ba2

Device Description

ARK™ Pregabalin Urine Calibrator is intended for use in calibration of the ARK™ Pregabalin Urine Assay.

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
DLJ	Calibrators, Drug Specific	Clinical Toxicology	862.3200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61980	Multiple anticonvulsant therapeutic drug monitoring IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement and therapeutic monitoring of multiple anticonvulsant drugs, also known as antiepileptic drugs which may include carbamazepine, lamotrigine, phenytoin, and primidone, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858724003292	GS1

Customer Contacts

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

Storage Conditions

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