The VITEK 2 Fungal Susceptibility Card is intended for use with the VITEK 2 systems as an in vitro test to determine the susceptibility of clinically significant yeast to antifungal agents

The VITEK 2 Fungal Susceptibility Card is intended for use with the VITEK 2 systems as an in vitro test to determine the susceptibility of clinically significant yeast to antifungal agents
VITEK® 2 AST-YS05 - VITEK® 2 AST-YS05

A non-selective culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing on general microorganisms isolated from a clinical specimen.

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: 03573026373047

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 03573026529758

Package Quantity: 20

Package Discontinue Date: 8/19/2021 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: N/A

Device Id: 03573026529758

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