Etest is a quantitative technique for determining susceptibility of clinically significant yeast. It provides a gradient of 15 doubling dilutions for MIC determination.
Etest® FLUCONAZOLE - Etest® FLUCONAZOLE
Device Description
A graduated test strip or collection of reagents containing a specified concentration gradient of the antimicrobial fluconazole, intended to be used to determine the minimum inhibitory concentration (MIC) for a particular microorganism, isolated from a clinical specimen by culture.
Environmental Conditions
- 22.00
- -20.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: NGZ
Device Name: Susceptibility Test Plate, Antifungal
Device Class: 2
Physical State: N/A
Definition: The device is an in vitro diagnostic device intended for use in determining quantitative susceptibility of Candida species to various antifungal agents diluted in varying concentration in a microtiter plate format.
Submission Type ID: 1
Review Panel: MI
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 866.1640
Third Party Flag: N
Medical Specialty: MI
Device IdentifiersDevice Id: 03573026252861
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 03573026548889
Package Quantity: 100
Package Discontinue Date: 3/23/2018 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: N/A
Device Id: 03573026548889
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
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