Epstein Barr Virus VCA IgG ELISA EIA-2793

GUDID 04048474027938

The DRG Epstein Barr Virus – Viral Capsid antigen (EBV-VCA) IgG test system is an enzyme-linked immunosorbent assay (ELISA) designed for the qualitative detection of IgG class antibodies to Epstein-Barr Virus Viral Capsid Antigen in human serum. The Test System is intended to be used to evaluate serologic evidence of previous infection with Epstein-Barr Virus,

DRG Instruments Gesellschaft mit beschränkter Haftung

Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody avidity index IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04048474027938
NIH Device Record Key5ccd680b-0882-472f-b92b-58b7b7097063
Commercial Distribution StatusIn Commercial Distribution
Brand NameEpstein Barr Virus VCA IgG ELISA
Version Model NumberEIA-2793
Catalog NumberEIA-2793
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
GS104048474027938 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCDAntigen, Ebv, Capsid

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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