VITEK MS ready to use reagent for calibration and fine tuning of the VITEK MS instrument

VITEK MS ready to use reagent for calibration and fine tuning of the VITEK MS instrument
VITEK®MS - VITEK MS

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.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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: 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