VITEK® MS knowledge base v3.3

VITEK® MS knowledge base v3.3
VITEK® MS knowledge base v3.3 - 3.3

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.

No Data Available

No Data Available

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: 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