FDA.reportPublic FDA data

BD Kiestra™ Main Base

Primary DI
00382904460976
Brand
BD Kiestra™ Main Base
Company
BD Kiestra B.V.
Model
446097
Catalog number
446097
Device description
BD Kiestra™ Main Base
Published
2023-10-20
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
JQPCalculator/data processing module, for clinical use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQPCalculator/Data Processing Module, For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904460976PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904460976003829044609763829044609760382904460976

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory container/microscope slide robotic transfer system IVDAn assembly of electrically-powered robotic devices, a stand-alone device, or a belt conveyor intended to be used for the automated or semi-automated transfer of assay containers (e.g., test tubes, microplates), microscope slides/slide carriers, or racks between processing stations. The system may interface with individual instruments/analysers and other equipment, transporting assay containers between stations which may include specimen pipetting, reagent dispensing, incubation, microplate washing, agitation, barcode reading and/or optical reading.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)638-8663Technical_services@bd.com

Regulatory Flags#

DUNS number
417876166
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382904449087BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application4449084449082025-12-17
00382904472023BD Kiestra™ InoqulA+™4472024472022018-05-25
00382904472061BD Kiestra™ ReadA™ Compact4472064472062018-05-25
00382904472139BD Kiestra™ InoqulA+™ TLA4472134472132018-05-25
00382904469481BD Kiestra™ ReadA4469484469482023-09-14
00382904460921BD Kiestra™ T-junction4460924460922023-10-19
00382904469733BD Kiestra™ InoqulA4469734469732025-02-18
00382904460969BD Kiestra™ Regular Base4460964460962023-10-23
00382904460938BD Kiestra™ ErgonomicA Connector R4460934460932023-10-19
00382904460945BD Kiestra™ ErgonomicA Connector L4460944460942023-10-19
00382904460983BD Kiestra™ Corner4460984460982023-10-19
00382904469443BD Kiestra™ U-Turn4469444469442023-10-20
00382904469467BD Kiestra™ Straight4469464469462023-10-20
00382904469412BD Kiestra™ Frame4469414469412023-10-19
00382904469429BD Kiestra™ Main Base Light4469424469422023-10-19
00382904469436BD Kiestra™ Destacker4469434469432023-10-19
00382904469450BD Kiestra™ Standard Connector4469454469452023-10-19
00382904469474BD Kiestra™ Stacker4469474469472023-10-19
00382904960216BD Kiestra™ ErgonomicA Connection Panel4960214960212023-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810142374064SoftBiobankSCC SOFT COMPUTERJQP2026-05-05
00810142373975SoftBiochemistrySCC SOFT COMPUTERJQP2026-04-16
00810142373982SoftCytogeneticsSCC SOFT COMPUTERJQP2026-04-16
00810142373999SoftPathDxSCC SOFT COMPUTERJQP2026-04-16
00810142374002SoftFlowCytometrySCC SOFT COMPUTERJQP2026-04-16
00810142374019SoftHLASCC SOFT COMPUTERJQP2026-04-16
00810142374026SoftMolecularSCC SOFT COMPUTERJQP2026-04-16
00810142374033SoftGenomicsSCC SOFT COMPUTERJQP2026-04-16
00810142374040SoftTrackSCC SOFT COMPUTERJQP2026-04-16
00810142373586SoftTotalQCSCC SOFT COMPUTERJQP2026-03-28
00810142373715SoftBiochemistrySCC SOFT COMPUTERJQP2026-03-12
00810142373722SoftCytogeneticsSCC SOFT COMPUTERJQP2026-03-12
00810142373739SoftPathDxSCC SOFT COMPUTERJQP2026-03-12
00810142373746SoftFlowCytometrySCC SOFT COMPUTERJQP2026-03-12
00810142373753SoftHLASCC SOFT COMPUTERJQP2026-03-12
00810142373760SoftMolecularSCC SOFT COMPUTERJQP2026-03-12
00810142373777SoftGenomicsSCC SOFT COMPUTERJQP2026-03-12
00810142373784SoftTrackSCC SOFT COMPUTERJQP2026-03-12
00810142373340SoftTotalQCSCC SOFT COMPUTERJQP2026-03-11
00810142373593SoftBiochemistrySCC SOFT COMPUTERJQP2026-02-21
00810142373609SoftCytogeneticsSCC SOFT COMPUTERJQP2026-02-21
00810142373616SoftPathDxSCC SOFT COMPUTERJQP2026-02-21
00810142373623SoftFlowCytometrySCC SOFT COMPUTERJQP2026-02-21
00810142373630SoftHLASCC SOFT COMPUTERJQP2026-02-21
00810142373647SoftMolecularSCC SOFT COMPUTERJQP2026-02-21
00810142373654SoftGenomicsSCC SOFT COMPUTERJQP2026-02-21
00810142373661SoftTrackSCC SOFT COMPUTERJQP2026-02-21
00810142373500SoftBiochemistrySCC SOFT COMPUTERJQP2026-02-04
00810142373517SoftCytogeneticsSCC SOFT COMPUTERJQP2026-02-04
00810142373524SoftPathDxSCC SOFT COMPUTERJQP2026-02-04