MBT HT Sepsityper CA Module

GUDID 04251204328285

Bruker Daltonik GmbH

Human infectome analysis interpretive software IVD
Primary Device ID04251204328285
NIH Device Record Keyfdb35234-0089-4d4d-9101-ba7ab9d909d8
Commercial Distribution StatusIn Commercial Distribution
Brand NameMBT HT Sepsityper CA Module
Version Model Number1892646
Company DUNS318387958
Company NameBruker Daltonik GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)442-2231
Emailms.support.us@bruker.com
Phone+1(877)442-2231
Emailms.support.us@bruker.com
Phone+1(877)442-2231
Emailms.support.us@bruker.com
Phone+1(877)442-2231
Emailms.support.us@bruker.com
Phone+1(877)442-2231
Emailms.support.us@bruker.com
Phone+1(877)442-2231
Emailms.support.us@bruker.com
Phone+1(877)442-2231
Emailms.support.us@bruker.com
Phone+1(877)442-2231
Emailms.support.us@bruker.com
Phone+1(877)442-2231
Emailms.support.us@bruker.com
Phone+1(877)442-2231
Emailms.support.us@bruker.com
Phone+1(877)442-2231
Emailms.support.us@bruker.com
Phone+1(877)442-2231
Emailms.support.us@bruker.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104251204328285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QBNMass spectrometry, MALDI TOF, microorganism identification, cultured isolates

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-08
Device Publish Date2025-11-28

Devices Manufactured by Bruker Daltonik GmbH

04251204328278 - MBT Compass HT CA2025-12-08
04251204328285 - MBT HT Sepsityper CA Module2025-12-08
04251204328285 - MBT HT Sepsityper CA Module2025-12-08
04251204328728 - MBT FAST Shuttle US IVD2025-12-08
04251204326182 - MBT Sepsityper Kit US IVD2021-02-19 Preparation kit for positive blood cultures in conjunction with MBT-CA System, for clinical use in USA
04251204326298 - MBT Galaxy System - US IVD2021-02-19 Workstation to disperse reagents onto clinical samples for use with MBT-CA System, for clinical use in USA
04251204326304 - MBT Pilot System - US IVD2021-02-19 Visual support for manual sample preparation for use with MBT-CA System, for clinical use in USA
04251204326175 - MALDI Biotyper-BD sirius CA System2020-12-17 Biotyper system for clinical use in the USA, with smartbeam laser.
04251204326311 - MALDI Biotyper sirius one CA System2020-12-17 Biotyper system for clinical use in the USA, with smartbeam laser.

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