QMS Topiramate Assay

Basic Information

• Brand Name: QMS Topiramate Assay
• Primary DI: 00884883012707
• Version / Model: 10017218
• Company Name: Microgenics Corporation
• Labeler DUNS: 122153799
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 4
• Public Version Date: 2020-06-19
• Public Version Status: Update
• Public Device Record Key: d4324a11-c704-4aba-96a4-957a66dc7bb9

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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
NWM	Immunoassay, Anti-Seizure Drug	Clinical Toxicology	862.3350	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60904	Topiramate therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry	A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the central nervous system drug topiramate in a clinical specimen, using a nephelometry/turbidimetry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00884883012707	GS1

Premarket Submissions

Submission Number	Supplement Number
K070645	000