FDA.reportPublic FDA data

Alinity

Primary DI
00380740197742
Brand
Alinity
Company
Abbott Ireland Diagnostics
Model
04W2127
Catalog number
04W2127
Device description
HSV-2 IgG Reagent Kit 200 Tests
Published
2025-10-14
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
MYFEnzyme linked immunosorbent assay, herpes simplex virus, hsv-2

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYFEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2Microbiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243575000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243575000ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG ControlsBiokit, S.A.2025-02-12MYF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740197742PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740197742003807401977423807401977420380740197742

GMDN Terms#

Term, Definition table
TermDefinition
Herpes simplex virus 2 (HSV2) 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 herpes simplex virus 2 (HSV2) in a clinical specimen, using a chemiluminescent immunoassay method.

Storage And Handling#

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

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
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
00380740213893AlinityAbbott Ireland DiagnosticsMYF2025-10-14
00380740213909AlinityAbbott Ireland DiagnosticsMYF2025-10-14
00850054026088AccuDiag ™Diagnostic Automation, Inc.MYF2023-06-27
07613336170687Elecsys HSV-2 IgGRoche Diagnostics GmbHMYF2022-12-06
07613336170694Elecsys HSV-2 IgGRoche Diagnostics GmbHMYF2022-12-06
00842768022807Atellica IM Herpes-2 IgGSiemens Healthcare Diagnostics Inc.MYF2022-10-28
03610522051236Bio-RadBio-RAD Laboratories, Inc.MYF2019-05-28
00630414016726ADVIA Centaur Herpes-2 IgGSiemens Healthcare Diagnostics Inc.MYF2019-04-09
10816101022370HSV-2 IgG Antigen WellsDIASORIN MOLECULAR LLCMYF2017-07-11
04015630940448Elecsys HSV-2 IgGRoche Diagnostics GmbHMYF2017-04-21
00850487007128ReQuest QUEST INTERNATIONAL, INC.MYF2016-10-31
08056771600101LIAISON® HSV-2 Type Specific IgGDiasorin Inc.MYF2016-09-24
04049016096733Anti-HSV-2 (gG2) ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGMYF2016-09-24
05391516743501Trinity BiotechCLARK LABORATORIES, INC.MYF2016-09-23
05391516743518Trinity BiotechCLARK LABORATORIES, INC.MYF2016-09-23
05391516747059Trinity BiotechCLARK LABORATORIES, INC.MYF2016-09-23
10816101022110HSV-2 ELISA IgG Cutoff CalibratorDIASORIN MOLECULAR LLCMYF2016-09-22
10816101022127HSV-2 ELISA IgG High Positive ControlDIASORIN MOLECULAR LLCMYF2016-09-22
10816101022134HSV-2 ELISA IgG Low Positive ControlDIASORIN MOLECULAR LLCMYF2016-09-22
10816101022172HSV-2 ELISA IgG ConjugateDIASORIN MOLECULAR LLCMYF2016-09-22
20816101022186HerpeSelect® 2 ELISA IgGDIASORIN MOLECULAR LLCMYF2016-09-22
20816101022193HerpeSelect® 2 ELISA IgGDIASORIN MOLECULAR LLCMYF2016-09-22
05391516743327Trinity BiotechCLARK LABORATORIES, INC.MYF2016-09-21
05391516746939Trinity BiotechCLARK LABORATORIES, INC.MYF2016-09-21
04015630939053Elecsys HSV2 IgG ImmunoassayRoche Diagnostics GmbHMYF2016-09-20
00847865000949BioPlex 2200BIO-RAD LABORATORIES, INC.MYF2016-09-12
00847865002172BioPlex 2200BIO-RAD LABORATORIES, INC.MYF2016-09-12
00847865002479BioPlex 2200BIO-RAD LABORATORIES, INC.MYF2016-09-12
00847865004725BioPlex 2200BIO-RAD LABORATORIES, INC.MYF2016-09-12
00847865010993BioPlex 2200BIO-RAD LABORATORIES, INC.MYF2016-09-12