FDA.reportPublic FDA data

Alinity

Primary DI
00380740181109
Brand
Alinity
Company
Abbott Ireland Diagnostics
Model
07P4233
Catalog number
07P4233
Device description
Alinity i CMV IgG Reagent Kit (1000T)
Published
2023-07-14
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
LFZENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFZEnzyme Linked Immunoabsorbent Assay, CytomegalovirusMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740181109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740181109003807401811093807401811090380740181109

GMDN Terms#

Term, Definition table
TermDefinition
Cytomegalovirus (CMV) 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 cytomegalovirus (CMV) 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
00380740168780Alinity04W022204W02222025-12-11
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816870024240CMV IgG AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LFZ2024-09-13
00816870024257CMV IgG AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LFZ2024-09-13
00816870024288CMV IgM AccuBind ELISA Test System - 96 WellsMONOBIND, INC.LFZ2024-09-13
00816870024295CMV IgM AccuBind ELISA Test System - 192 WellsMONOBIND, INC.LFZ2024-09-13
04048474027976CMV IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLFZ2023-08-29
00840239027979CMV IgG ELISA DRG International IncLFZ2023-08-24
00380740181093AlinityAbbott Ireland DiagnosticsLFZ2023-07-14
07613336193082Elecsys CMV IgGRoche Diagnostics GmbHLFZ2022-12-07
07613336198469Elecsys CMV IgGRoche Diagnostics GmbHLFZ2022-12-06
00894175000558AccuDiag™Diagnostic Automation, Inc.LFZ2021-11-29
00894175000053AccuDiag ™ Diagnostic Automation, Inc.LFZ2021-08-10
B3507203200Gold Standard Diagnostics Is-CMV IgG ELISA Test KitGold Standard Diagnostics CorporationLFZ2020-06-03
05391516746885Trinity BiotechCLARK LABORATORIES, INC.LFZ2019-12-27
00630414588872ADVIA Centaur CMV IgGSiemens Healthcare Diagnostics Inc.LFZ2019-02-10
00630414246635Atellica IM CMV IgGSiemens Healthcare Diagnostics Inc.LFZ2018-11-30
03610520150269BioPlex 2200BIO-RAD LABORATORIES, INC.LFZ2017-08-05
03610521167488BioPlex 2200BIO-RAD LABORATORIES, INC.LFZ2017-08-05
03610520992715BioPlex 2200BIO-RAD LABORATORIES, INC.LFZ2017-08-05
04015630940172Elecsys CMV IgGRoche Diagnostics GmbHLFZ2017-04-21
04015630940189Elecsys CMV IgMRoche Diagnostics GmbHLFZ2017-04-17
08056771101943LIAISON® CMV IgMDIASORIN SPALFZ2016-09-24
00630414961231IMMULITE® 2000 Systems CVG CMV IgGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLFZ2016-09-24
00630414963822IMMULITE®/IMMULITE® 1000 Systems CMV CMV IgGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLFZ2016-09-24
05391516745024Trinity BiotechCLARK LABORATORIES, INC.LFZ2016-09-22
05391516745031Trinity BiotechCLARK LABORATORIES, INC.LFZ2016-09-22
05391516743419Trinity BiotechCLARK LABORATORIES, INC.LFZ2016-09-21
05391516743426Trinity BiotechCLARK LABORATORIES, INC.LFZ2016-09-21
05391516746991Trinity BiotechCLARK LABORATORIES, INC.LFZ2016-09-21
04015630937172Elecsys CMV IgG AssayRoche Diagnostics GmbHLFZ2016-09-20
04015630938926Elecsys CMV IgM ImmunoassayRoche Diagnostics GmbHLFZ2016-09-20