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Gold Standard Diagnostics Is-HSV 1&2 IgG ELISA Test Kit

Primary DI
B3507203400
Brand
Gold Standard Diagnostics Is-HSV 1&2 IgG ELISA Test Kit
Company
Gold Standard Diagnostics Corporation
Model
720-340
Catalog number
720-340
Device description
ImmunoSimplicity (Is) HSV 1&2 IgG Test for the detection of IgG antibodies to herpes simplex virus (HSV) type 1 and/or type 2 as an aid in the diagnosis of a primary or reactivated infection with HSV.
Published
2020-08-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LGCEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGCEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-SpecificMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B3507203400PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)A 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 1 and/or herpes simplex virus 2 (HSV1 & 2) in a clinical specimen, using an enzyme immunoassay (EIA) method.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
790524891
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
B3507207900Gold Standard Diagnostics Is-ANA Screen ELISA Test Kit720-790720-7902025-02-26
B350GSD0113000Gold Standard Diagnostics Anti-nuclear Antibody (ANA) Screening Test KitGSD01-13002016-09-27
B350GSD0116005C0Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5CGSD01-1600-5CGSD01-1600-5C2024-12-06
B350GSD051600MW0Microtiterplates (5)GSD05-1600-MWGSD05-1600-MW2024-10-22
B35000400R0AIX1000 Analyzer00400R00400R2023-10-31
B350GSD011600DYE0AIX1000 Performance Check Dye KitGSD01-1600-DYEGSD01-1600-DYE2023-09-13
B350GSD051600NC0RPR Non-Reactive ControlGSD05-1600-NCGSD05-1600-NC2023-09-13
B350GSD051600PC0RPR Reactive ControlGSD05-1600-PCGSD05-1600-PC2023-09-13
B350GSD1600WCASE0MicrotiterplatesGSD-1600-W-CASEGSD-1600-W-CASE2022-10-14
B350004000AIX1000 Analyzer004002016-11-29
B350GSD0116000Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test SystemGSD01-16002016-09-27
B350GSD341600R0Gold Standard Diagnostics RPR Reagent PackGSD34-1600-RGSD34-1600-R2016-11-29
B350GSD011600DIL0GSD RPR DiluentGSD01-1600-DILGSD01-1600-DIL2025-10-16
B350GSD0110010Gold Standard Diagnostics H. pylori ELISA IgA Test KitGSD01-10012016-09-27
B350GSD051600W0GSD RPR Microtiterplate - 5 pack sleeveGSD05-1600-WGSD05-1600-W2022-11-25
B350GSD011029CP0SARS-CoV-2 Component PackGSD01-1029-CPGSD01-1029-CP2022-10-07
B350GSD011029SP0SARS-CoV-2 IgA Sera PackGSD01-1029-SPGSD01-1029-SP2022-10-07
B350GSD011002RP0IgM Reagent PackGSD01-1002-RPGSD01-1002-RP2022-10-28
B350GSD011002CP0H. pylori IgM Sera PackGSD01-1002-CPGSD01-1002-CP2022-10-07
B350GSD011002HCP0H. pylori Component PackGSD01-1002-HCPGSD01-1002-HCP2022-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850054026644QMedix™Diagnostic Automation, Inc.LGC2024-06-25
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00894175000046AccuDiag ™ Diagnostic Automation, Inc.LGC2021-08-10
B3507203500Gold Standard Diagnostics Is-HSV 1&2 IgM ELISA Test KitGold Standard Diagnostics CorporationLGC2020-06-03
00630414016726ADVIA Centaur Herpes-2 IgGSiemens Healthcare Diagnostics Inc.LGC2019-04-09
00630414964171IMMULITE® / IMMULITE® 1000 Systems HER Herpes I and II IgGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLGC2016-09-24
00630414999784IMMULITE® 2000 Systems Herpes I and II IgGSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDLGC2016-09-24
05391516743709Trinity BiotechCLARK LABORATORIES, INC.LGC2016-09-23
05391516746489Trinity BiotechCLARK LABORATORIES, INC.LGC2016-09-23
10816101021014HSV-1 AND HSV-2 Differentiation Immunoblot IgG Antigen StripsDIASORIN MOLECULAR LLCLGC2016-09-22
10816101021021HSV-1 and HSV-2 Immunoblot IgG Cutoff/Positive ControlDIASORIN MOLECULAR LLCLGC2016-09-22
10816101021038HSV-1 and HSV-2 Immunoblot IgG Negative ControlDIASORIN MOLECULAR LLCLGC2016-09-22
20816101021004HerpeSelect® 1 and 2 Immunoblot IgGDIASORIN MOLECULAR LLCLGC2016-09-22
00817273020174DiamedixDIAMEDIX CORPORATIONLGC2016-09-20
05391516746496Trinity BiotechCLARK LABORATORIES, INC.LGC2016-09-19
00847865010740Bio-Rad Laboratories, Inc.Bio-RAD Laboratories, Inc.LGC2016-09-12
00850487007142ReQuestQUEST INTERNATIONAL, INC.LGC2016-08-31
00850487007333SeraQuestQUEST INTERNATIONAL, INC.LGC2016-08-31
00811727015211Pointe Scientific, Inc. HSV-1 & 2 IgGHORIBA INSTRUMENTS INCORPORATEDLGC2016-08-31
00816057020577ASI HSV IgG EIA TestARLINGTON SCIENTIFIC, INC.LGC2016-07-08