The VITEK MS
VITEK® MS CHCA - VITEK® MS CHCA
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
- 8.00
- 2.00
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
Device IdentifiersDevice Id: 03573026362836
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 03573026556662
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: N/A
Device Id: 03573026556662
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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