Device |
system, mass spectrometry, maldi tof, microorganism identification, cultured isolates |
Regulation Description |
Mass spectrometer system for clinical use for the identification of microorganisms. |
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. |
Physical State |
In vitro diagnostic device |
Technical Method |
Matrix-assisted laser desorption/ionization - time of flight (MALDI-TOF) mass spectrometry |
Target Area |
Identification of microorganisms cultured from human specimens |
Regulation Medical Specialty |
Microbiology |
Review Panel |
Microbiology |
Product Code | PEX |
Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Microbiology Devices
(DMD)
|
Submission Type |
510(k)
|
Regulation Number |
866.3361
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Ineligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |