FDA.reportPublic FDA data

MicroScan

Primary DI
15099590655549
Brand
MicroScan
Company
Beckman Coulter, Inc.
Model
B1013-5
Device description
MicroScan RENOK Disposable D-Inoculator Sets
Published
2022-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
15099590655549PrimaryGS10
05099590655542Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1509959065554915099590655549
05099590655542050995906555425099590655542

GMDN Terms#

Term, Definition table
TermDefinition
General-microorganism antimicrobial susceptibility culture medium IVDA non-selective culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing on general microorganisms isolated from a clinical specimen.

Regulatory Flags#

DUNS number
008254708
Device count
60
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15099590807696UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter)D30863D308632026-05-19
15099590806323Access anti-HBc IgM D22920D229202026-05-04
15099590806330Access anti-HBc IgM CalibratorD22921D229212026-05-04
15099590806347Access anti-HBc IgM QCD22922D229222026-05-04
15099590806446Access anti-HAV IgMD25834D258342026-04-23
15099590806453Access anti-HAV IgM CalibratorD25835D258352026-04-23
15099590806460Access anti-HAV IgM QCD25836D258362026-04-23
15099590233501Synchron4725004725002016-08-24
15099590786533Access BNP IID06227D062272026-03-30
15099590806293Hepatitis B Virus core Total AntibodyD22917D229172026-03-30
15099590806309ACCESS anti-HBc Total CALIBRATORD22918D229182026-03-30
15099590806316ACCESS anti-HBc Total QCD22919D229192026-03-30
15099590572822Cytomics FC500UPS (MPL)6265542016-09-23
15099590572839Cytomics FC500UPS (CXP)6265532016-09-23
15099590736002Access PCTC53987C539872023-05-05
15099590806255ACCESS HBsAgD229132026-01-16
15099590806262ACCESS HBsAg ConfirmatoryD229142026-01-16
15099590806279Access HBsAg CALIBRATORD229152026-01-16
15099590806286ACCESS HBsAg QCD229162026-01-16
15099590806415ACCESS anti-HAVD258312026-01-16

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
00382904469733BD Kiestra™ InoqulABD Kiestra B.V.JTC2025-02-18
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
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