FDA.reportPublic FDA data

BRUKER SCIENTIFIC LLC

Matched from indexed company URL: Bruker Scientific LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30039613813003961381BRUKER SCIENTIFIC LLC1N2026-01-0140 Manning Rd Billerica MA US 01821

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00841594100024MALDI Biotyper CA System - Biotyper system for clinical use in the USA.+1(877)442-2231ms.support.us@bruker.com
00841594100031MALDI Biotyper - smart CA - Biotyper system for clinical use in the USA, with smart laser.+1(877)442-2231ms.support.us@bruker.com
00841594110030MBT-CA System BD - Biotyper system for clinical use in the USA, for Becton Dickinson.+1(877)442-2231ms.support.us@bruker.com
00841594110047BD Bruker MBT smart CA System - Biotyper system for clinical use in the USA with smart laser, for Becton Dickson.+1(877)442-2231ms.support.us@bruker.com
00841594110054US IVD 48 Spot Target - Reuseable Stainless Steel Target.+1(877)442-2231ms.support.us@bruker.com
10841594110013US IVD-HCCA Matrix, Portioned 10 Tubes - HCCA Matrix, 10 tubes+1(877)442-2231ms.support.us@bruker.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1582502028273627K193419MBT SepsityperQNJ2020-12-27
1582501331896078K163536MALDI Biotyper CA (MBT-CA) System, MBT smart CA SystemPEX2017-07-26
1582501707395324K142677MALDI Biotyper CA SystemPEX2015-03-27
1582501589066761K130831MALDI BIOTYPER CA (MBT-CA) SYSTEMPEX2013-11-21

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PEX32017-07-26
QNJ12020-12-27

GUDID#