ARK™ Methotrexate II Control

Basic Information

• Brand Name: ARK™ Methotrexate II Control
• Primary DI: 00812101031209
• Version / Model: 5071-0003-01
• Catalog Number: 5071-0003-01
• Company Name: ARK DIAGNOSTICS INC
• Labeler DUNS: 164880598
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-24
• Public Version: 1
• Public Version Date: 2024-11-01
• Public Version Status: New
• Public Device Record Key: 3a766cd0-cdbb-4b28-90a8-bfd13994c5a6

Device Description

ARK™ Methotrexate II Control is intended for use in quality control of the ARK Methotrexate II 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
LAO	Enzyme Immunoassay, Methotrexate	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
38535	Methotrexate therapeutic drug monitoring IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement and therapeutic monitoring of the antineoplastic drug methotrexate in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812101031209	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K232017	000

Storage Conditions

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