VITEK® MS knowledge base v3.3
VITEK® MS knowledge base v3.3 - 3.3
Device Description
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.
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: 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 IdentifiersDevice Id: 03573026628154
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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