FDA.reportPublic FDA data

Axis-Shield Active-B12 (Holotranscobalamin) EIA

Primary DI
05055845400046
Brand
Axis-Shield Active-B12 (Holotranscobalamin) EIA
Company
AXIS-SHIELD DIAGNOSTICS LIMITED
Model
FMABT100
Catalog number
FMABT100
Device description
The Axis-Shield Active-B12 (Holotranscobalamin) assay is an enzyme-immunoassay (EIA) for the quantitative determination of holotranscobalamin (HoloTC) in human serum. HoloTC (vitamin B12 bound to transcobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency.
Published
2016-09-02
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121946000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121946000AXIS-SHIELD ACVTIVE-B12Axis-Shield Diagnostics, Ltd.2013-03-22CDD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055845400046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055845400046050558454000465055845400046

GMDN Terms#

Term, Definition table
TermDefinition
Vitamin B12 IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of vitamin B12 in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+441382422000MDL-AXD-Product-Support@alere.
+441382422000MDL-AXD-Product-Support@alere.com
+1-877-441-7440USproductsupport@abbott.com

Regulatory Flags#

DUNS number
229062427
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
05055845400596Alere NT-proBNP for Alinity Reagent Kit (200 Tests)04S792104S79212025-02-26
05055845400497Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptide) EIAFCCP600FCCP6002019-08-02
05055845400008Axis-Shield Anti-CCP (Cyclic, Citrullinated Peptide) EIAFCCP600FCCP6002016-09-01
05055845400015Axis® Homocysteine EIAFHCY100FHCY1002016-06-13
05055845400022Axis-Shield Homocysteine ControlsFHCY200FHCY2002016-07-01
050558454000843-Reagent Homocysteine Assay for SYNCHRON UniCelFHYB100/B08175FHYB100/B081752016-07-01
05055845400169Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent KitFHRWR100FHRWR1002016-07-01
05055845400176Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent KitFHRWR200FHRWR2002016-07-01
05055845400183Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent KitFHRWR1000FHRWR10002016-07-01
05055845400282Axis-Shield Liquid Stable (LS) 2-Part Homocysteine ReagentFHBC100/B08176FHBC100/B081762016-07-01
05055845400527Alere NT-proBNP for Alinity Control Kit04S791104S79112025-02-27
05055845400534Alere NT-proBNP for Alinity Calibrator Kit04S790204S79022025-02-27

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