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Bruker Daltonik GmbH

US

Last updated May 30, 2026

Information

Country: US
Address: —
Website: bruker.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(877)442-2231
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 318387958

Catalogue (18)

Device	Model / Reference	Registries	Class	Status
US IVD-HCCA Matrix, Portioned 10 Tubes/7.5mg each	1852132	FDA UDI	Class II	Active
MALDI Biotyper sirius one CA System	1890232	FDA UDI	Class II	Active
US IVD-HCCA Matrix, Portioned 10 Tubes	8604531	FDA UDI	Class II	Active
US IVD 48 Spot Target	8604532	FDA UDI	Class II	Active
MALDI Biotyper - smart CA	8604784	FDA UDI	Class II	Active
MBT Biotarget 96 US IVD	1840380	FDA UDI	Class II	Active
MALDI Biotyper-BD sirius one CA System	1890233	FDA UDI	Class II	Active
MBT Galaxy System - US IVD	1875054	FDA UDI	Class II	Active
MBT Sepsityper Kit US IVD	1867565	FDA UDI	Class II	Active
MALDI Biotyper CA System	8603464	FDA UDI	Class II	Active
MBT-CA System BD	8604736	FDA UDI	Class II	Active
MALDI Biotyper-BD sirius CA System	1890133	FDA UDI	Class II	Active
MALDI Biotyper sirius CA System	1890132	FDA UDI	Class II	Active
US IVD-Bruker Bacterial Test Standard, 5 Tubes	8604530	FDA UDI	Class II	Active
MBT Pilot System - US IVD	1875058	FDA UDI	Class II	Active
MBT Sepsityper	K193419	FDA 510(k)	Class II	Active
MALDI Biotyper CA (MBT-CA) System, MBT smart CA System	K163536	FDA 510(k)	Class II	Active
MALDI Biotyper CA System	DEN170081	FDA 510(k)	Class II	Active

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