GENTC

Basic Information

• Brand Name: GENTC
• Primary DI: 00884883007123
• Version / Model: 08772525 190
• Company Name: Microgenics Corporation
• Labeler DUNS: 122153799
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-20
• Public Version: 1
• Public Version Date: 2019-11-28
• Public Version Status: New
• Public Device Record Key: 1276897b-cae9-4e60-9cae-8fe08c0d3994

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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
LCD	Enzyme Immunoassay, Gentamicin	Clinical Toxicology	862.3450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55274	Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the antimicrobial drug gentamicin 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	00884883007123	GS1

Premarket Submissions

Submission Number	Supplement Number
K913470	000