FDA.reportPublic FDA data

Alinity

Primary DI
00380740213879
Brand
Alinity
Company
Abbott Ireland Diagnostics
Model
04W2002
Catalog number
04W2002
Device description
HSV-1 IgG Calibrator
Published
2024-05-14
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
MXJEnzyme linked immunosorbent assay, herpes simplex virus, hsv-1

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MXJEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1Microbiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213987000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213987000ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG ControlsBiokit, S.A.2023-09-20MXJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00380740213879PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00380740213879003807402138793807402138790380740213879

GMDN Terms#

Term, Definition table
TermDefinition
Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to herpes simplex virus 1 (HSV1) 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
+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
00816870024332HSV 1+2 IgG AccuLite® CLIA Test System (6775-300A, 6775-300B)MONOBIND, INC.MXJ2024-09-13
00816870024363HSV 1+2 IgM AccuBind® ELISA Test System (6825-300A, 6825-300B)MONOBIND, INC.MXJ2024-09-13
00816870024370HSV 1+2 IgM AccuLite® CLIA Test System (6875-300A, 6875-300B)MONOBIND, INC.MXJ2024-09-13
00380740197704AlinityAbbott Ireland DiagnosticsMXJ2024-05-14
00380740213886AlinityAbbott Ireland DiagnosticsMXJ2024-05-14
00850054026095AccuDiag ™Diagnostic Automation, Inc.MXJ2023-06-27
07613336170656Elecsys HSV-1 IgGRoche Diagnostics GmbHMXJ2022-12-06
07613336170663Elecsys HSV-1 IgGRoche Diagnostics GmbHMXJ2022-12-06
00842768022784Atellica IM Herpes-1 IgGSiemens Healthcare Diagnostics Inc.MXJ2022-10-28
03610522051076Bio-RadBio-RAD Laboratories, Inc.MXJ2019-05-28
00630414016740ADVIA Centaur Herpes-1 IgGSiemens Healthcare Diagnostics Inc.MXJ2019-04-09
10816101022356DxSelect™ - 10X Wash BufferDIASORIN MOLECULAR LLCMXJ2017-07-11
10816101022363HSV-1 IgG Antigen WellsDIASORIN MOLECULAR LLCMXJ2017-07-11
10816101022387HerpeSelect ELISA Sample DiluentDIASORIN MOLECULAR LLCMXJ2017-07-11
10816101022301DxSelect™ - Stop ReagentDIASORIN MOLECULAR LLCMXJ2017-07-11
10816101022295DxSelect™ - Substrate ReagentDIASORIN MOLECULAR LLCMXJ2017-07-11
04015630940431Elecsys HSV-1 IgGRoche Diagnostics GmbHMXJ2017-04-21
00850487007135ReQuestQUEST INTERNATIONAL, INC.MXJ2016-11-30
00850487007548SeraQuestQUEST INTERNATIONAL, INC.MXJ2016-11-30
08056771600231LIAISON® HSV-1 Type Specific IgGDiasorin Inc.MXJ2016-09-24
08056771600248LIAISON® Control HSV-1 IgGDiasorin Inc.MXJ2016-09-24
04049016096726Anti-HSV-1 (gC1) ELISA (IgG)EUROIMMUN Medizinische Labordiagnostika AGMXJ2016-09-24
05391516743471Trinity BiotechCLARK LABORATORIES, INC.MXJ2016-09-23
05391516743488Trinity BiotechCLARK LABORATORIES, INC.MXJ2016-09-23
05391516747035Trinity BiotechCLARK LABORATORIES, INC.MXJ2016-09-23
10816101022073HSV-1 ELISA IgG Cutoff CalibratorDIASORIN MOLECULAR LLCMXJ2016-09-22
10816101022080HSV ELISA Negative ControlDIASORIN MOLECULAR LLCMXJ2016-09-22
10816101022097HSV-1 ELISA IgG High Positive ControlDIASORIN MOLECULAR LLCMXJ2016-09-22
10816101022103HSV-1 ELISA IgG Low Positive ControlDIASORIN MOLECULAR LLCMXJ2016-09-22
10816101022165HSV-1 ELISA IgG ConjugateDIASORIN MOLECULAR LLCMXJ2016-09-22