FDA.reportPublic FDA data

LIAISON® Vitamin B12

Primary DI
08056771602532
Brand
LIAISON® Vitamin B12
Company
Diasorin Inc.
Model
318320
Published
2019-12-04
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
CDDRadioassay, Vitamin B12

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056771602532PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056771602532080567716025328056771602532

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

Contacts#

Phone, Email table
PhoneEmail
651-439-9710info@diasorin.com

Regulatory Flags#

DUNS number
033429783
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056771104418LIAISON QuantiFERON TB Gold Plus II3110852026-02-20
18056771104415LIAISON QuantiFERON TB Gold Plus II3110852026-02-20
08056771104470LIAISON Control QuantiFERON TB Gold Plus II3110812026-02-20
08056771104401LIAISON QuantiFERON TB Gold Plus II3110802026-02-19
08056771600811ANAFLUOR™16622016-09-24
08056771600828ANAFLUOR™16602016-09-24
08056771600835ANAFLUOR ™16242016-09-24
08056771600842ANAFLUOR™66242016-09-24
08056771600859ANAFAST™ ANA Fluorescent Test System 240 Wells16702016-09-24
08056771600897CT-3 Immunoscreen Fluoro-Kit™17402016-09-24
08056771600903CT-2 Immunoscreen Fluoro-Kit™17412016-09-24
08056771600910RS Fluoro-Kit™19702016-09-24
08056771600927ANAFLUOR™ Combo-Pak18122016-09-24
08056771600934ANA HEp-2 6-well Slide Pack16632016-09-24
08056771600941ANA HEp-2 12-well Slide Pack16612016-09-24
08056771600965CT-3 6-well Slide Pack18012016-09-24
08056771600972CT-2 Slide Pack16312016-09-24
08056771601030Fluorescent Antibody (HEp-2) Conjugate16642016-09-24
08056771600118LIAISON® Control HSV-2 IgG3106212016-09-24
08056771602778LIAISON 25 OH Vitamin D Total Assay 200 test3183602021-04-13

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
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
04015630939848Elecsys Vitamin B12 IIRoche Diagnostics GmbHCDD2017-04-21