Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010191749

FEI Number

3010191749

Entity Name

Bruker Daltonics

City/State/Country

Bremen, DE

Establishment Address

Fahrenheitstrasse 4, Bremen 28359, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Bruker Scientific LLC (Owner Number: 10044152)

Owner / Operator Contact Address

40 Manning Road, Billerica, MA 01821, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K130831

PMA Number

N/A

All Registered Proprietary Names

MBT Pilot System US IVD MBT Sepsityper MBT Sepsityper Kit US IVD MBT Biotarget 96 US IVD MALDI Biotyper-BD sirius CA System MALDI Biotyper sirius CA System MBT-BD sirius one CA System MBT-BD sirius CA System MALDI Biotyper sirius one CA System MBT sirius one CA System MALDI Biotyper-BD sirius one CA System MBT sirius CA System US IVD HCCA Portioned for MBT Galaxy MBT-CA System BD Bruker MALDI Biotyper CA System US IVD 48 Spot Target MALDI Biotyper CA System US IVD HCCA Portioned BD Bruker MBT-CA System US IVD BTS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QNJ	Mass Spectrometry, Microorganism Identification, Blood Culture	Microbiology	Class 2	866.3378	2021-02-09
PEX	System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates	Microbiology	Class 2	866.3361	2017-11-06
PEX	System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates	Microbiology	Class 2	866.3361	2013-12-12

Official Correspondent

No official correspondent registered.

US Agent Details

Doug Roderick Business: BRUKER SCIENTIFIC LLC Email: Doug.Roderick@bruker.com Phone: (978) 6633660

Related Public Records

Same Entity

Bruker Scientific LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003961381	BRUKER SCIENTIFIC LLC	Billerica, MA, US
3018426298	InVivo BioTech Services GmbH	Berlin, DE

Similar Registrations

Registration Number	Establishment Name	Location
3044320359	ELITechGroup Inc., Tucson	Tucson, AZ, US
3018426298	InVivo BioTech Services GmbH	Berlin, DE
9615754	BIOMERIEUX SA	LA BALME LES GROTTES Isere, FR
3003961381	BRUKER SCIENTIFIC LLC	Billerica, MA, US
3010099434	KRATOS ANALYTICAL LTD.	Manchester, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010191749. Last updated year: 2026. Please use registration number 3010191749 when referencing this establishment in official correspondence.