FDA.reportPublic FDA data

Alinity

Primary DI
00380740189815
Brand
Alinity
Company
Abbott GmbH
Model
09P2635
Catalog number
09P2635
Device description
Alinity i Active B-12 (Holotranscobalamin) Reagent Kit
Published
2026-01-01
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
CDDRadioassay, vitamin b12

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233541000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233541000ARCHITECT Active-B12 (Holotranscobalamin)Axis-Shield Diagnostics, Ltd.2024-07-31CDD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740189815PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740189815003807401898153807401898150380740189815

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, also known as cobalamin, in a clinical specimen, using a chemiluminescent immunoassay.

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
+1(877)422-2688xx@xx.xx

Regulatory Flags#

DUNS number
315786293
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
00380740132552Alinity09P842009P84202023-11-16
00380740208622ARCHITECT4P52-2204P52222026-05-15
00380740208639Alinity08P432108P43212026-05-15
00380740193645ARCHITECT1P31-2701P31272026-04-28
00380740117207Alinity06P066006P06602019-10-12
00380740167455Alinity06P060306P06032019-10-12
00380740167462Alinity06P062006P06202019-10-12
00380740167479Alinity06P062406P06242019-10-12
00380740139032ARCHITECT06P222706P22272017-08-16
00380740139049ARCHITECT06P223706P22372017-08-16
00380740011130ARCHITECT6L23-0106L23012014-11-18
00380740189785Alinity09P262509P26252026-01-01
00380740189792ARCHITECT3P24-2803P24282026-01-01
00380740189808ARCHITECT3P24-3803P24382026-01-01
00380740189822Alinity09P260209P26022026-01-01
00380740189839Alinity09P261109P26112026-01-01
00380740189846ARCHITECT3P24-0203P24022026-01-01
00380740189853ARCHITECT3P24-1103P24112026-01-01
00380740223748Alinity09P261D09P261D2026-01-01
00380740186241Alinity04T991A04T991A2025-12-19

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
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
04015630939848Elecsys Vitamin B12 IIRoche Diagnostics GmbHCDD2017-04-21