FDA.reportPublic FDA data

US IVD 48 Spot Target

Primary DI
10841594110020
Brand
US IVD 48 Spot Target
Company
BRUKER DALTONICS INC.
Model
8604532
Catalog number
8604532
Device description
Reuseable Stainless Steel Target.
Published
2016-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
10841594110020PackageGS15Not in Commercial Distribution
00841594110054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084159411002010841594110020
00841594110054008415941100548415941100540841594110054

GMDN Terms#

Term, Definition table
TermDefinition
Microplate IVDA plate with multiple wells designed to contain small volumes of clinical specimens, reagents, or other materials for testing procedures performed by a laboratory analyser. It is typically made of sterilizable plastic material (e.g., polypropylene) and is used with manual or automated analysers. This is a single-use device.

Sterilization Methods#

Method table
Method
Peracetic Acid

Contacts#

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

Regulatory Flags#

DUNS number
877298661
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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
04251204325642US IVD-Bruker Bacterial Test Standard, 5 TubesBruker 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