Bruker Daltonics, Inc.
United StatesFDA 510(k) applicant, unverified
Part of Bruker Daltonics GmbH & Co. KG
- Devices
- 2
What Bruker Daltonics, Inc. makes
Bruker Daltonics, Inc. manufactures mass spectrometry systems designed for microbial identification and characterization, including the MALDI Biotyper CA System and MALDI BIOTYPER CA (MBT-CA) SYSTEM. These devices use matrix-assisted laser desorption/ionization (MALDI) technology to analyze microbial samples for clinical applications, such as pathogen identification in infectious disease diagnostics.
The company’s portfolio is regulated under Class II medical devices in the United States, with relevant products listed via the FDA’s 510(k) clearance process. These systems are intended for use in laboratory settings and are governed by U.S. regulatory standards for diagnostic devices.
Catalogue
MALDI Biotyper CA System Ref K142677
510(k) 510(k)Maldi Biotyper Ca (Mbt-Ca) System Ref K130831
510(k) 510(k)
Frequently asked questions
How many devices does Bruker Daltonics, Inc. have in the registry?
The registry currently lists 2 devices for Bruker Daltonics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bruker Daltonics, Inc.'s devices?
Among its 2 most recently registered devices, Bruker Daltonics, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Bruker Daltonics, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Bruker Daltonics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bruker Daltonics, Inc. in the registry?
The most recently registered devices listed for Bruker Daltonics, Inc. include MALDI Biotyper CA System and MALDI BIOTYPER CA (MBT-CA) SYSTEM.