EBV-EA IgG ELISA EIA-2796

GUDID 00840239027962

The DRG Epstein Barr Virus Early Antigen (EBV-EA) IgG ELISA test system provides a means for the qualitative detection of IgG class antibodies to Epstein-Barr Virus (EBV) Early Antigen (EA) in human sera. This test is intended to aid in the diagnosis of infectious mononucleosis (IM) when used with other EBV serological tests. The performance characteristics have not been established to aid in the diagnosis of acute IM.

DRG International Inc

Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00840239027962
NIH Device Record Key9fe0a899-e373-49ae-b239-427b6acaee51
Commercial Distribution StatusIn Commercial Distribution
Brand NameEBV-EA IgG ELISA
Version Model NumberEIA-2796
Catalog NumberEIA-2796
Company DUNS075150847
Company NameDRG International Inc
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

Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@drg-international.com
Phone9735647555
Emailcorpoffice@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
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
GS100840239027962 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LSEEpstein-Barr Virus, Other

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-01
Device Publish Date2023-08-24

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