The VITEK® MS Software is a computer application which supports the microbiology laboratory workflow for the VITEK® MS Systems.

The VITEK® MS Software is a computer application which supports the microbiology laboratory workflow for the VITEK® MS Systems.
VITEK® MS SOFTWARE v1.1 - VITEK MS SW V1.1

An assembly of mains electricity (AC-powered) devices intended to be used for the qualitative detection and identification of microbial species (bacteria, fungi) in a clinical specimen using mass spectrometry. It typically consists of a sample handling/preparation unit, a mass spectrometry instrument, and a server with software intended to analyse results and compare the produced spectra with information in a remote database to identify and report the microbial species in the specimen. The system operates with reduced technician involvement and automation of some, but not all, procedural steps.

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Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PEX

Device Name: System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

Device Class: 2

Physical State: In vitro diagnostic device

Definition: A mass spectrometer system using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) mass spectrometry

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Identification of microorganisms cultured from human specimens

Regulation Number: 866.3361

Third Party Flag: N

Medical Specialty: MI

Code: QBN

Device Name: Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

Device Class: 2

Physical State: In vitro diagnostic device

Definition: The MALDI Biotyper CA System is a mass spectrometer system using matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) for the identification and differentiation of microorganisms cultured from human specimens. The MALDI Biotyper CA System is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Matrix-assisted laser desorption/ionization time of flight (MALDI-TOF) mass spectrometry

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Identification and differentiation of microorganisms cultured from human specimens

Regulation Number: 866.3378

Third Party Flag: N

Medical Specialty: MI

Device Id: 03573026621698

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