Last synced on 20 December 2024 at 11:05 pm

Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

Page Type
Product Code
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.
Physical State
In vitro diagnostic device
Technical Method
Matrix-assisted laser desorption/ionization time of flight (MALDI-TOF) mass spectrometry
Target Area
Identification and differentiation of microorganisms cultured from human specimens
Regulation Medical Specialty
Microbiology
Review Panel
Microbiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
866.3378
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QBN is linked to regulation 21CFR866.3378, which does not seem to exist yet. It may be pending at the moment.

Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates

Page Type
Product Code
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.
Physical State
In vitro diagnostic device
Technical Method
Matrix-assisted laser desorption/ionization time of flight (MALDI-TOF) mass spectrometry
Target Area
Identification and differentiation of microorganisms cultured from human specimens
Regulation Medical Specialty
Microbiology
Review Panel
Microbiology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
866.3378
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

Product code QBN is linked to regulation 21CFR866.3378, which does not seem to exist yet. It may be pending at the moment.