VITEK®2 software 9.01 update, advanced software to run your VITEK®2 system, second version


Product Overview

VITEK®2 software 9.01 update, advanced software to run your VITEK®2 system, second version
VITEK®2 - 9.01.1


Device Description

An electrically-powered laboratory instrument intended to be used for the identification of bacteria and/or yeast isolated from clinical specimens and for the determination of their antimicrobial susceptibility profile using morphology, substrate utilization and/or biochemical reactivity and by monitoring growth rates and/or determining endpoint growth, against a range of antimicrobials. Growth detection technology used may include immunoassay, colorimetry, fluorimetry, chromatography and/or carbon dioxide production. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.


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: LON

Device Name: System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

Device Class: 2

Physical State: N/A

Definition: N/A

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: 866.1645

Third Party Flag: N

Medical Specialty: MI


Device Identifiers

Device Id: 03573026619060

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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