The VITEK REVEAL Reveal AST Assays are indicated for susceptibility testing of pathogenic bacteria

The VITEK REVEAL Reveal AST Assays are indicated for susceptibility testing of pathogenic bacteria
VITEK® REVEAL™ SENSOR PANEL - VITEK® REVEAL™ SENSOR PANEL

A susceptibility testing disc impregnated with a defined amount of a specific an antibacterial, also known as an antibiotic (i.e., a drug intended for treatment and/or prevention of a bacterial infection) intended to be used to determine the susceptibility of a specific bacterial organism (excluding mycobacteria) isolated from a clinical specimen by culture, using a disc diffusion method.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: SAN

Device Name: Automated Antimicrobial Susceptibility Test System For Positive Blood Culture Samples

Device Class: 2

Physical State: In vitro diagnostic device

Definition: Automated system that performs antimicrobial susceptibility testing using positive blood culture samples

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Antimicrobial susceptibility testing of microbes detected in positive blood cultures

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: For antimicrobial susceptibility testing using positive blood cultures

Regulation Number: 866.1650

Third Party Flag: N

Medical Specialty: MI

Device Id: 03573026638900

Device Type: Unit of Use

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

Device Id: 00860007326929

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