- Physicians Office Resource

The VITEK REVEAL Instrument is a benchtop instrument that processes up to four AST tests . Installation and operating details for the Reveal Instrument are provided in this manual.
VITEK® REVEAL™ - 900-00001

Device Description

An electrically-powered automated or semi-automated laboratory instrument intended to be used for the in vitro determination of an antimicrobial susceptibility profile by monitoring the growth rate of a microbiological organism from a clinical specimen and/or culture isolate when exposed to a range ofantimicrobials. Growth detection technology used may include immunoassay, colorimetry, chromatography, photometric and/or carbon dioxide production.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

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 Identifiers

Device Id: 00860007326905

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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