Etest is a quantitative technique for determining susceptibility of clinically significant yeast. It provides a gradient of 15 doubling dilutions for MIC determination.

Etest is a quantitative technique for determining susceptibility of clinically significant yeast. It provides a gradient of 15 doubling dilutions for MIC determination.
Etest® ITRACONAZOLE - Etest® ITRACONAZOLE

A graduated test strip or collection of reagents containing a specified concentration gradient of a specific antifungal/antimycotic (i.e., a drug intended for treatment and/or prevention of a fungal infection) intended to be used to determine the minimum inhibitory concentration (MIC) for a particular microorganism, isolated from a clinical specimen by culture.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 03573026253318

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 03573026549091

Package Quantity: 100

Package Discontinue Date: 3/28/2019 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: N/A

Device Id: 03573026549091

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