Knowledge Base Update for VITEK2 Software

Knowledge Base Update for VITEK2 Software
VITEK® 2 KB UPDATE V2S - 9.03

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.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 03573026613914

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