Etest® GEMIFLOXACIN

Basic Information

• Brand Name: Etest® GEMIFLOXACIN
• Primary DI: 03573026550585
• Version / Model: Etest® GEMIFLOXACIN
• Company Name: BIOMERIEUX SA
• Labeler DUNS: 276816717
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-12
• Public Version: 5
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: b7c53b9f-6ee2-4397-850b-f8cfd7de7a7b
• Distribution End Date: 2017-06-30

Device Description

GEMIFLOXACIN GEM 32 US S30

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: 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
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	866.1640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45559	Gemifloxacin minimum inhibitory concentration (MIC) IVD	A graduated test strip or collection of reagents containing a specified concentration gradient of the antimicrobial gemifloxacin, intended to be used to determine the minimum inhibitory concentration (MIC) for a particular microorganism, isolated from a clinical specimen by culture.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	03573026377854	GS1		30	Not in Commercial Distribution	2017-06-30
Primary	03573026550585	GS1

Premarket Submissions

Submission Number	Supplement Number
K042390	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 8 Degrees Celsius