InVivo BioTech Services GmbH

FDA Device Registration & Listing · Berlin, DE · Registration 3018426298

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3018426298
FEI Number
3013735140
Entity Name
InVivo BioTech Services GmbH
City/State/Country
Berlin, DE
Establishment Address
Oranienstrasse 24, Berlin 10999, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Bruker Scientific LLC (Owner Number: 10044152)
Owner / Operator Contact Address
40 Manning Road, Billerica, MA 01821, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

MBT Pilot System US IVD MBT Sepsityper MBT Sepsityper Kit US IVD 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 2013-12-12

Official Correspondent

Doug Roderick

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
3010191749 Bruker Daltonics Bremen, DE

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018426298. Last updated year: 2026. Please use registration number 3018426298 when referencing this establishment in official correspondence.
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