FDA.reportPublic FDA data

MBT HT Sepsityper CA Module

Primary DI
04251204328285
Brand
MBT HT Sepsityper CA Module
Company
Bruker Daltonik GmbH
Model
1892646
Published
2025-11-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QBNMass spectrometry, MALDI TOF, microorganism identification, cultured isolates

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QBNMass Spectrometry, Maldi Tof, Microorganism Identification, Cultured IsolatesMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251495000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251495000MBT Compass HT CA Software; MBT FAST Shuttle US IVDBruker Daltonics GmbH & Co. KG2025-08-13QBN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251204328285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251204328285042512043282854251204328285

GMDN Terms#

Term, Definition table
TermDefinition
Human infectome analysis interpretive software IVDAn in vitro diagnostic interpretive software program intended to be used to aid the identification of infectious microbial species [bacterial, fungal, viral] in a clinical specimen using images from microbial cultures and laboratory biochemical tests (e.g., digital profiles), or by genetic profiling via nucleic acid analysis. Results from in vitro diagnostic tests are input and the presumptive name(s), probability of possible microbial species, and/or information on genetic variants (e.g., subtype, genotype, strain) are returned.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)442-2231ms.support.us@bruker.com

Regulatory Flags#

DUNS number
318387958
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251204328278MBT Compass HT CA18926452025-11-28
04251204328728MBT FAST Shuttle US IVD18961332025-11-28
04251204326182MBT Sepsityper Kit US IVD186756518675652021-02-11
04251204326298MBT Galaxy System - US IVD187505418750542021-02-11
04251204326304MBT Pilot System - US IVD187505818750582021-02-11
04251204300014MALDI Biotyper CA System860346486034642017-02-25
04251204325642US IVD-Bruker Bacterial Test Standard, 5 Tubes860453086045302017-02-25
04251204325659US IVD-HCCA Matrix, Portioned 10 Tubes860453186045312017-02-25
04251204325666US IVD 48 Spot Target860453286045322017-02-25
04251204325710MBT-CA System BD860473686047362017-02-25
04251204325734MALDI Biotyper - smart CA860478486047842017-02-25
04251204326175MALDI Biotyper-BD sirius CA System189013318901332020-12-09
04251204326311MALDI Biotyper sirius one CA System189023218902322020-12-09
04251204326359MALDI Biotyper-BD sirius one CA System189023318902332020-12-09
04251204326168MALDI Biotyper sirius CA System189013218901322019-07-01
04251204325772MBT Biotarget 96 US IVD184038018403802018-01-31
04251204325789US IVD-HCCA Matrix, Portioned 10 Tubes/7.5mg each185213218521322018-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251204328278MBT Compass HT CABruker Daltonik GmbHQBN2025-11-28
04251204328728MBT FAST Shuttle US IVDBruker Daltonik GmbHQBN2025-11-28
03573026637200VITEK® MS SOFTWARE v1.2BIOMERIEUX SAQBN2025-04-29
03573026626211VITEK®MSBIOMERIEUX SAQBN2024-03-08
03573026617851VITEK®MSBIOMERIEUX SAQBN2024-03-08
18050148217975Colibrí™ Primary Tube with WaterCOPAN WASP SRLQBN2024-01-31
18052870817966Colibrí™ Primary Tube with SalineCOPAN WASP SRLQBN2024-01-31
58050148217973Colibrí™ Primary Tube with WaterCOPAN WASP SRLQBN2024-01-31
58052870817964Colibrí™ Primary Tube with SalineCOPAN WASP SRLQBN2024-01-31
03573026628154VITEK® MS knowledge base v3.3BIOMERIEUX SAQBN2023-11-14
00382904440633BD Kiestra™ IdentifABECTON, DICKINSON AND COMPANYQBN2023-05-31
08050148218005Colibri Daily Verification KitCOPAN WASP SRLQBN2022-11-15
18050148212864Colibri SpreaderCOPAN WASP SRLQBN2022-11-15
18050148217968Colibrí™ Primary Tube for VITEK 2COPAN WASP SRLQBN2022-11-15
58050148218208Colibrí™COPAN WASP SRLQBN2022-11-15
03573026611422VITEK® MS PRIMEBIOMERIEUX SAQBN2022-04-25
58052870816202Colibrí™ SystemCOPAN WASP SRLQBN2022-01-27
58052870818428Colibrí™ Vision SystemCOPAN WASP SRLQBN2022-01-27
58052870818435Colibrí™ Preparation StationCOPAN WASP SRLQBN2022-01-27
03573026621698VITEK® MS SOFTWARE v1.1BIOMERIEUX SAQBN2021-11-03