FDA.reportPublic FDA data

Alinity

Primary DI
00380740168780
Brand
Alinity
Company
Abbott Ireland Diagnostics
Model
04W0222
Catalog number
04W0222
Device description
Alinity i Rubella IgG Reagent Kit
Published
2025-12-11
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
LFXENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFXEnzyme Linked Immunoabsorbent Assay, RubellaMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740168780PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740168780003807401687803807401687800380740168780

GMDN Terms#

Term, Definition table
TermDefinition
Rubella virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Rubella virus in a clinical specimen, using a chemiluminescent immunoassay method.

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
985307301
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
00380740153953Alinity01R182101R18212019-01-04
00380740168742Alinity04W020104W02012025-12-11
00380740168759Alinity04W021004W02102025-12-11
00380740197742Alinity04W212704W21272025-10-14
00380740213893Alinity04W210204W21022025-10-14
00380740213909Alinity04W211204W21122025-10-14
00380740136772Alinity06P020406P02042019-09-14
00380740136789Alinity06P035906P03592019-09-14
00380740136796Alinity06P021306P02132019-09-14
00380740136802Alinity06P021506P02152019-09-14
00380740136819Alinity06P026006P02602019-09-14
00380740150990Alinity09P412009P41202020-05-05
00380740154233Alinity09P414009P41402020-05-05
00380740154240Alinity09P424009P42402020-01-02
00380740154516Alinity09P422009P42202020-01-02
00380740001339ARCHITECT1L76-0101L76012016-06-06
00380740001346ARCHITECT1L76-2501L76252016-06-06
00380740001353ARCHITECT1L76-5501L76552016-06-06
00380740001360ARCHITECT1L77-0101L77012016-06-06
00380740001377ARCHITECT1L77-2501L77252016-06-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336218440Elecsys Rubella IgMRoche Diagnostics GmbHLFX2024-10-24
00816870024165Rubella IgG AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LFX2024-09-13
00816870024172Rubella IgG AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LFX2024-09-13
00816870024202Rubella IgM AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LFX2024-09-13
00816870024219Rubella IgM AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LFX2024-09-13
00850049545686AccuDiag ™Diagnostic Automation, Inc.LFX2023-06-14
00850049545693AccuDiag ™Diagnostic Automation, Inc.LFX2023-06-14
B3507203600Gold Standard Diagnostics Is-Rubella IgG ELISA Test KitGold Standard Diagnostics CorporationLFX2020-07-27
05391516746519Trinity BiotechCLARK LABORATORIES, INC.LFX2019-12-27
05391516746526Trinity BiotechCLARK LABORATORIES, INC.LFX2019-12-27
05391516746533Trinity BiotechCLARK LABORATORIES, INC.LFX2019-12-27
05391516746878Trinity BiotechCLARK LABORATORIES, INC.LFX2019-12-27
05391516746748Trinity BiotechCLARK LABORATORIES, INC.LFX2019-12-26
05391516746786Trinity BiotechCLARK LABORATORIES, INC.LFX2019-12-26
00630414599830Atellica IM Rub MSiemens Healthcare Diagnostics Inc.LFX2018-02-06
00630414599847Atellica IM Rub M QCSiemens Healthcare Diagnostics Inc.LFX2018-02-06
00630414600529Atellica IM Rub GSiemens Healthcare Diagnostics Inc.LFX2018-02-06
00630414600536Atellica IM Rub G QCSiemens Healthcare Diagnostics Inc.LFX2018-02-06
04015630940257Elecsys Rubella IgMRoche Diagnostics GmbHLFX2017-05-10
04015630940240Elecsys Rubella IgGRoche Diagnostics GmbHLFX2017-04-21
10859035006245Alere Rubella-plus®ALERE NORTH AMERICA, LLCLFX2016-09-24
08056771100571LIAISON® Rubella IgGDIASORIN SPALFX2016-09-24
00630414201412ADVIA Centaur® Rub GSiemens Healthcare Diagnostics Inc.LFX2016-09-24
00630414201429ADVIA Centaur® Rub G QCSiemens Healthcare Diagnostics Inc.LFX2016-09-24
00630414201436ADVIA Centaur® Rub MSiemens Healthcare Diagnostics Inc.LFX2016-09-24
00630414201443ADVIA Centaur® Rub M QCSiemens Healthcare Diagnostics Inc.LFX2016-09-24
00630414962054IMMULITE® 2000 Systems RUB Rubella Quantitative IgGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLFX2016-09-24
00630414962061IMMULITE® 2000 Systems RUB Rubella Quantitative IgGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLFX2016-09-24
00630414964614IMMULITE®/IMMULITE® 1000 Systems RUB Rubella Quantitative IgGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLFX2016-09-24
00630414971469IMMULITE® 2000 Systems RUM Rubella IgMSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLFX2016-09-24