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Gold Standard Diagnostics Is-VZV IgG ELISA Test Kit

Primary DI
B3507203800
Brand
Gold Standard Diagnostics Is-VZV IgG ELISA Test Kit
Company
Gold Standard Diagnostics Corporation
Model
720-380
Catalog number
720-380
Device description
ImmunoSimplicity Varicella Zoster Virus (Is-VZV) IgG ELISA test for the qualitative and semi-quantitative detection of IgG antibodies to VZV to determine a prior exposure to VZV and to aid in the determination of acute or convalescent stage of VZV infection.
Published
2020-05-20
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
LFYEnzyme Linked Immunoabsorbent Assay, Varicella-Zoster

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFYEnzyme Linked Immunoabsorbent Assay, Varicella-ZosterMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981867000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981867000IS-VZU IGG TEST SYSTEMDiamedix Corp.1998-09-28LFY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B3507203800PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Varicella-zoster virus (VZV) 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 varicella-zoster virus (VZV) 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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04048474028089Varicella Zoster Virus (VZV) IgG ELISA DRG Instruments Gesellschaft mit beschränkter HaftungLFY2023-08-29
00840239028082Varicella Zoster Virus (VZV) IgG ELISA DRG International IncLFY2023-08-24
05391516746755Trinity BiotechCLARK LABORATORIES, INC.LFY2019-12-26
05391516746793Trinity BiotechCLARK LABORATORIES, INC.LFY2019-12-26
05391516746830Trinity BiotechCLARK LABORATORIES, INC.LFY2019-12-26
05391516743532Trinity BiotechCLARK LABORATORIES, INC.LFY2016-09-23
00817273020228DiamedixDIAMEDIX CORPORATIONLFY2016-09-20
00847865000727BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865000734BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865000741BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865000758BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865000765BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865002189BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865002264BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865002332BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
00847865010757Bio-Rad Laboratories, Inc.Bio-RAD Laboratories, Inc.LFY2016-09-12
00847865010979BioPlex 2200BIO-RAD LABORATORIES, INC.LFY2016-09-12
03573026064518VIDAS® Varicella-Zoster IgGBIOMERIEUX SALFY2016-08-31
00850487007012ReQuestQUEST INTERNATIONAL, INC.LFY2016-08-31
00850487007340SeraQuestQUEST INTERNATIONAL, INC.LFY2016-08-31
00816057020584ASI VZV IgG EIA TestARLINGTON SCIENTIFIC, INC.LFY2016-07-08