Varicella Zoster Virus (VZV) IgG ELISA EIA-2808

GUDID 04048474028089

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.

DRG Instruments Gesellschaft mit beschränkter Haftung

Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04048474028089
NIH Device Record Keya299d51f-8282-4a43-a35b-f5333a611cb3
Commercial Distribution StatusIn Commercial Distribution
Brand NameVaricella Zoster Virus (VZV) IgG ELISA
Version Model NumberEIA-2808
Catalog NumberEIA-2808
Company DUNS317134468
Company NameDRG Instruments Gesellschaft mit beschränkter Haftung
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com
Phone973-564-7555
Emailcorp@drg-international.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104048474028089 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFYEnzyme Linked Immunoabsorbent Assay, Varicella-Zoster

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-06
Device Publish Date2023-08-29

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