Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
QBN · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3378
Classification
FDA Product Code
QBN
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.3378
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.