FDA.reportPublic FDA data

BD Kiestra™ InoqulA

Primary DI
00382904469733
Brand
BD Kiestra™ InoqulA
Company
BD Kiestra B.V.
Model
446973
Catalog number
446973
Device description
BD Kiestra™ InoqulA
Published
2025-02-18
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
JTCDEVICE, MICROTITER DILUTING/DISPENSING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTCDevice, Microtiter Diluting/DispensingMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904469733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904469733003829044697333829044697330382904469733

GMDN Terms#

Term, Definition table
TermDefinition
Microbial specimen inoculation/streaking/colony-picking instrument IVDAn electrically-powered instrument intended for the pre-analytical preparation of microbial samples (e.g., cultures, suspensions, MALDI-TOF targets/slides) from a clinical specimen and/or culture isolate. Its functionality includes: 1) automated/semi-automated transfer of the clinical specimen (e.g., by aspiration or inoculating loop), inoculation into/onto culture dishes/tubes/slides, and streaking of culture dishes (e.g., using magnetic beads, inoculation loops or spreaders); and/or 2) automated microbial colony picking for the preparation of samples for subsequent analytical procedures. It may also feature processing capabilities such as barcoding, storage, and/or sorting.

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
00382904460969BD Kiestra™ Regular Base4460964460962023-10-23
00382904460976BD Kiestra™ Main Base4460974460972023-10-20
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
58059796363919Slide Prep Evo™COPAN WASP SRLJTC2026-02-26
58059796363926Pipettor ModuleCOPAN WASP SRLJTC2026-02-26
58059796363506WASP®COPAN WASP SRLJTC2024-11-21
00810044208047Caplugs/EvergreenCAPlugsJTC2024-05-31
00810044208054Caplugs/EvergreenCAPlugsJTC2024-05-31
00810044208061Caplugs/EvergreenCAPlugsJTC2024-05-31
00810044208078Caplugs/EvergreenCAPlugsJTC2024-05-31
00810044208252Caplugs/EvergreenCAPlugsJTC2024-05-31
00810044208269Caplugs/EvergreenCAPlugsJTC2024-05-31
00810044208276Caplugs/EvergreenCAPlugsJTC2024-05-31
00810044208283Caplugs/EvergreenCAPlugsJTC2024-05-31
08800066300111ASFA® SPOTTERMBD CO., Ltd.JTC2023-11-21
06936895300083BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JTC2023-07-05
06936895300090BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JTC2023-07-05
06936895300106BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JTC2023-07-05
06936895300113BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JTC2023-07-05
06936895300076BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JTC2023-07-04
03610520010877BIO RADBIO-RAD LABORATORIES, INC.JTC2023-02-03
00848838022333REMELREMEL, INC.JTC2023-01-03
15099590655532MicroScanBeckman Coulter, Inc.JTC2022-12-13
15099590655549MicroScanBeckman Coulter, Inc.JTC2022-12-13
15099590655556MicroScanBeckman Coulter, Inc.JTC2022-12-13
15099590702052MicroScanBeckman Coulter, Inc.JTC2022-12-13
15099590658236MicroScanBeckman Coulter, Inc.JTC2022-11-15
00894175000497Diagnostic AutomationDiagnostic Automation, Inc.JTC2021-09-16
58050148211414WASP®COPAN WASP SRLJTC2021-04-27
58050148218277Pipettor ModuleCOPAN WASP SRLJTC2021-04-27
58050148218970Slide Prep Evo™COPAN WASP SRLJTC2021-04-27
58052870813669Collaborative StationCOPAN WASP SRLJTC2021-04-27
08800066300012ASFA SPOTTERMBD CO., Ltd.JTC2020-01-29