FDA device listing
BD Bruker MALDI Biotyper CA System,BD Bruker MBT-CA System,MALDI Biotyper CA System,MBT Biotarget 96 US IVD,MBT-CA…
FDA device listing 1707395324 · Bruker Scientific LLC
Key facts
| Proprietary names | BD Bruker MALDI Biotyper CA System,BD Bruker MBT-CA System,MALDI Biotyper CA System,MBT Biotarget 96 US IVD,MBT-CA System |
|---|---|
| Owner/operator | Bruker Scientific LLC |
| Owner/operator number | 10044152 |
| Premarket submissions | K142677 |
| Product codes | PEX |
| Device names | PEX - System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates |
| Device class | Class II |
| Classification regulations (21 CFR) | 866.3361 |
| Review panels | Microbiology |
| Registered establishments | Bruker Daltonics, BRUKER SCIENTIFIC LLC |
| Establishment registrations | 3003961381, 3010191749 |
| FEI numbers | 3003961381, 3010191749 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database