FDA.reportPublic FDA data

US IVD-Bruker Bacterial Test Standard, 5 Tubes

Primary DI
04251204325642
Brand
US IVD-Bruker Bacterial Test Standard, 5 Tubes
Company
Bruker Daltonik GmbH
Model
8604530
Catalog number
8604530
Device description
Bacterial Test Standard, 5 tubes.
Published
2017-02-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PEXSystem, mass spectrometry, maldi tof, microorganism identification, cultured isolates

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130831000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130831000MALDI BIOTYPER CA (MBT-CA) SYSTEMBruker Daltonics, Inc.2013-11-21PEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251204325642PrimaryGS10
04251204325758Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251204325642042512043256424251204325642
04251204325758042512043257584251204325758

GMDN Terms#

Term, Definition table
TermDefinition
Brain-responsive electrical stimulation systemAn assembly of devices designed to continuously monitor brain activity and deliver electrical stimuli to seizure foci in response to the detection of abnormal electrical events in the brain for the treatment of neurological disorders (e.g., epilepsy). It consists of a sterile, battery-powered sensing device/stimulator implanted below the scalp; one or more leads, which may be placed on the cortical surface or deep in the brain, and which transmit monitoring data, electrocorticograms and stimulation pulses; telemetric control units for programming the stimulator and/or receiving functional data; and software run on a computing device for analysis and reporting.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature68 Degrees Fahrenheit77 Degrees Fahrenheit
Special Storage Condition, Specify00Max 8hr working time unrefridgerated.
Special Storage Condition, Specify00Min shelf life 12 months. Min shelf life 5 months frozen, reconstituted.
Storage Environment Temperature-18 Degrees Celsius-18 Degrees Celsius

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
5
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251204328278MBT Compass HT CA18926452025-11-28
04251204328285MBT HT Sepsityper CA Module18926462025-11-28
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
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
03573026637200VITEK® MS SOFTWARE v1.2BIOMERIEUX SAPEX2025-04-29
03573026628154VITEK® MS knowledge base v3.3BIOMERIEUX SAPEX2023-11-14
03573026621698VITEK® MS SOFTWARE v1.1BIOMERIEUX SAPEX2021-11-03
04251204326182MBT Sepsityper Kit US IVDBruker Daltonik GmbHPEX2021-02-11
04251204326298MBT Galaxy System - US IVDBruker Daltonik GmbHPEX2021-02-11
04251204326304MBT Pilot System - US IVDBruker Daltonik GmbHPEX2021-02-11
04251204326175MALDI Biotyper-BD sirius CA SystemBruker Daltonik GmbHPEX2020-12-09
04251204326311MALDI Biotyper sirius one CA SystemBruker Daltonik GmbHPEX2020-12-09
04251204326359MALDI Biotyper-BD sirius one CA SystemBruker Daltonik GmbHPEX2020-12-09
04251204326168MALDI Biotyper sirius CA SystemBruker Daltonik GmbHPEX2019-07-01
03573026610418VITEK®MSBIOMERIEUX SAPEX2019-04-30
04251204325772MBT Biotarget 96 US IVDBruker Daltonik GmbHPEX2018-01-31
04251204325789US IVD-HCCA Matrix, Portioned 10 Tubes/7.5mg eachBruker Daltonik GmbHPEX2018-01-31
03573026436971VITEK® MS MYCOBACTERIUM/NOCARDIA KITBIOMERIEUX SAPEX2017-08-21
03573026437282VITEK® MS MOULD KITBIOMERIEUX SAPEX2017-08-21
04251204300014MALDI Biotyper CA SystemBruker Daltonik GmbHPEX2017-02-25
04251204325659US IVD-HCCA Matrix, Portioned 10 TubesBruker Daltonik GmbHPEX2017-02-25
04251204325666US IVD 48 Spot TargetBruker Daltonik GmbHPEX2017-02-25
04251204325710MBT-CA System BDBruker Daltonik GmbHPEX2017-02-25
04251204325734MALDI Biotyper - smart CABruker Daltonik GmbHPEX2017-02-25
03573026554224VITEK® MS-DSBIOMERIEUX SAPEX2016-12-23
03573026359096VITEK® MS-DSBIOMERIEUX SAPEX2016-12-23
03573026555559VITEK® MS FABIOMERIEUX SAPEX2016-12-19
03573026556662VITEK® MS CHCABIOMERIEUX SAPEX2016-12-19
03573026362843VITEK® MS FABIOMERIEUX SAPEX2016-12-19
03573026359119VITEK® MSBIOMERIEUX SAPEX2016-11-09
00841594110047BD Bruker MBT smart CA SystemBruker Scientific LLCPEX2016-09-21
00841594110054US IVD 48 Spot TargetBruker Scientific LLCPEX2016-09-16
00841594100024MALDI Biotyper CA SystemBruker Scientific LLCPEX2016-09-16
00841594100031MALDI Biotyper - smart CABruker Scientific LLCPEX2016-09-16