FDA.reportPublic FDA data

Varicella Zoster Virus (VZV) IgG ELISA

Primary DI
04048474028089
Brand
Varicella Zoster Virus (VZV) IgG ELISA
Company
DRG Instruments Gesellschaft mit beschränkter Haftung
Model
EIA-2808
Catalog number
EIA-2808
Device description
The Varicella-Zoster Virus (VZV) IgG ELISA test system is intended for the qualitative detection of VZV IgG antibody in human serum. When performed according to these instructions, the results of this test, together with other clinical information, may aid in the determination of immune status, and/or aid in the diagnosis of VZV infections.
Published
2023-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K961012000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961012000VZV IGG ELISA TEST SYSTEMZeus Scientific, Inc.1996-07-24LFY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048474028089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048474028089040484740280894048474028089

GMDN Terms#

Term, Definition table
TermDefinition
Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the determination of the avidity index 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

Contacts#

Phone, Email table
PhoneEmail
973-564-7555corp@drg-international.com

Regulatory Flags#

DUNS number
317134468
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048474041170ANA Detect ELISAEIA-4117EIA-41172023-08-31
04048474027730ANA Screen IgG ELISA EIA-2773EIA-27732023-08-29
04048474035629ANA-8-Screen ELISAEIA-3562EIA-35622019-06-05
04048474035636ANA Combi (ANA-8-Profile) ELISAEIA-3563EIA-35632019-06-10
04048474018646TGF-Beta 1 ELISAEIA-1864EIA-18642024-11-22
04048474059670Measles Virus IgG Avidity ELISAEIA-5967EIA-59672023-09-01
04048474060591Giardia/Cryptosporidium Ag (stool) ELISA EIA-6059EIA-60592023-09-01
04048474027747DNA (ds) IgG ELISAEIA-2774EIA-27742023-08-29
04048474027938Epstein Barr Virus VCA IgG ELISAEIA-2793EIA-27932023-08-29
04048474027945Epstein Barr Virus VCA IgM ELISAEIA-2794EIA-27942023-08-29
04048474027969EBV-EA IgG ELISAEIA-2796EIA-27962023-08-29
04048474028157H. Pylori IgG ELISA EIA-2815EIA-28152023-08-29
04048474033717Gliadin IgG ELISA EIA-3371EIA-33712023-08-29
04048474034448Adenovirus Antigen (stool) ELISA EIA-3444EIA-34442023-08-29
04048474034677Cryptosporidium Antigen (stool) ELISA EIA-3467EIA-34672023-08-29
04048474034738Entamoeba histolytica Ag (stool) ELISA EIA-3473EIA-34732023-08-29
04048474034776Giardia lamblia Antigen (stool) ELISA EIA-3477EIA-34772023-08-29
04048474036022Anti-Lactoferrin ELISAEIA-3602EIA-36022023-08-29
04048474035520hGH ELISAEIA-3552EIA-35522019-06-10
04048474035612Anti TPO Ab ELISAEIA-3561EIA-35612019-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03573026644796VIDAS® Varicella-Zoster IgGBIOMERIEUX SALFY2026-01-19
00840239028082Varicella Zoster Virus (VZV) IgG ELISA DRG International IncLFY2023-08-24
B3507203800Gold Standard Diagnostics Is-VZV IgG ELISA Test KitGold Standard Diagnostics CorporationLFY2020-05-20
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