Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003961381

FEI Number

3003961381

Entity Name

BRUKER SCIENTIFIC LLC

City/State/Country

Billerica, MA, US

Establishment Address

40 Manning Rd, Billerica, MA 01821, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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

K142677

PMA Number

N/A

All Registered Proprietary Names

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 BD Bruker MALDI Biotyper CA System BD Bruker MBT-CA System MBT Biotarget 96 US IVD MBT-CA System MALDI Biotyper CA System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PEX	System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates	Microbiology	Class 2	866.3361	2013-12-12
PEX	System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates	Microbiology	Class 2	866.3361	2016-06-01

Official Correspondent

Doug Roderick

US Agent Details

No US Agent registered (Local establishment).

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
3018426298	InVivo BioTech Services GmbH	Berlin, DE
3010191749	Bruker Daltonics	Bremen, DE

Similar Registrations

Registration Number	Establishment Name	Location
9615754	BIOMERIEUX SA	LA BALME LES GROTTES Isere, FR
3018426298	InVivo BioTech Services GmbH	Berlin, DE
3010191749	Bruker Daltonics	Bremen, DE
3010099434	KRATOS ANALYTICAL LTD.	Manchester, GB
3028606342	OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD	Guangzhou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003961381. Last updated year: 2026. Please use registration number 3003961381 when referencing this establishment in official correspondence.