FDA.reportPublic FDA data

Access Vitamin B12

Primary DI
H628330001
Brand
Access Vitamin B12
Company
Beckman Coulter, Inc.
Model
33000
Catalog number
33000
Published
2015-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CDDRadioassay, Vitamin B12

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDDRadioassay, Vitamin B12Clinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H628330001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vitamin B12 IVD kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of vitamin B12 in a clinical specimen, using a chemiluminescent immunoassay.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008254708
Device count
1
Kit
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
00380740189785AlinityAbbott GmbHCDD2026-01-01
00380740189792ARCHITECTAbbott GmbHCDD2026-01-01
00380740189808ARCHITECTAbbott GmbHCDD2026-01-01
00380740189815AlinityAbbott GmbHCDD2026-01-01
15099590224301Access Vitamin B12Beckman Coulter, Inc.CDD2025-09-09
00630414600307Atellica IM VB12 MCMSiemens Healthcare Diagnostics Inc.CDD2020-09-24
00630414293554Atellica IM Calibrator CSiemens Healthcare Diagnostics Inc.CDD2020-05-31
00630414293820Atellica IM VB12Siemens Healthcare Diagnostics Inc.CDD2020-05-31
00630414294100Atellica IM Calibrator CSiemens Healthcare Diagnostics Inc.CDD2020-05-31
00630414294261Atellica IM VB12Siemens Healthcare Diagnostics Inc.CDD2020-05-31
08056771602532LIAISON® Vitamin B12Diasorin Inc.CDD2019-12-04
00380740150525AlinityAbbott GmbHCDD2019-06-07
00816870020280Folate, Vit B12 Anemia Panel AccuBind VAST ELISA Test System - 96 WellsMONOBIND, INC.CDD2019-02-11
00816870020297Folate, Vit B12 Anemia Panel AccuBind VAST ELISA Test System - 192 WellsMONOBIND, INC.CDD2019-02-11
00816870020365Vit B12 AccuBind ELISA Test System - 96 WellsMONOBIND, INC.CDD2019-02-11
00816870020372Vit B12 AccuBind ELISA Test System - 192 WellsMONOBIND, INC.CDD2019-02-11
00816870021966Folate, Vit B12 Anemia Panel AccuLite VAST CLIA Test System - 96 WellsMONOBIND, INC.CDD2019-02-11
00816870021973Monobind AccuLite Folate & Vit B12 VAST CLIA Kit - 192 WellsMONOBIND, INC.CDD2019-02-11
00816870022048Vit B12 AccuLite CLIA Test System - 96 WellsMONOBIND, INC.CDD2019-02-11
00816870022055Vit B12 AccuLite CLIA Test System - 192 WellsMONOBIND, INC.CDD2019-02-11
00380740136703AlinityABBOTT IRELANDCDD2019-01-02
00380740136697AlinityABBOTT IRELANDCDD2018-11-12
00630414245720Atellica IM AB12Siemens Healthcare Diagnostics Inc.CDD2018-10-19
00630414598611Atellica IM CKMB MCMSiemens Healthcare Diagnostics Inc.CDD2018-02-06
00630414600277Atellica IM VB12Siemens Healthcare Diagnostics Inc.CDD2018-02-06
00630414600284Atellica IM VB12Siemens Healthcare Diagnostics Inc.CDD2018-02-06
00630414600291Atellica IM VB12 DILSiemens Healthcare Diagnostics Inc.CDD2018-02-06
00630414600314Atellica IM VB12 DTT/RELSiemens Healthcare Diagnostics Inc.CDD2018-02-06
00630414598338Atellica IM Calibrator CSiemens Healthcare Diagnostics Inc.CDD2017-12-27
00630414598345Atellica IM Calibrator CSiemens Healthcare Diagnostics Inc.CDD2017-12-22