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 C
| Device Type ID | 3588 |
| Device Name | Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates |
| 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 |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3378 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QBN |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3588 |
| Device | Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates |
| Product Code | QBN |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 866.3378 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOMERIEUX | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOMERIEUX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BRUKER DALTONIK GMBH | ||
GRANTED | 1 | |