VITEK MS ready to use reagent for calibration and fine tuning of the VITEK MS instrument
VITEK®MS - VITEK MS
Device Description
A collection of reagents and other associated materials intended to be used to calibrate or verify the performance of a mass spectrometry analyser to ensure its proper function, prior to analysis/processing of clinical samples.
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: 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: 03573026617851
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 03573026626211
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: N/A
Device Id: 03573026626211
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