AccessGUDID - DEVICE: Epstein Barr Virus VCA IgG ELISA (04048474027938)

GUDID

Device Identifier (DI) Information

Brand Name: Epstein Barr Virus VCA IgG ELISA
Version or Model: EIA-2793
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EIA-2793
Company Name: DRG Instruments Gesellschaft mit beschränkter Haftung

Primary DI Number: 04048474027938
Issuing Agency: GS1
Commercial Distribution End Date: July 11, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 317134468 *Terms of Use

Device Description: 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,

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
49673	Epstein-Barr virus (EBV) VCA 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 the viral capsid antigen (VCA) of Epstein-Barr virus (EBV) in a clinical specimen, using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Epstein-Barr virus (EBV), the virus associated with infectious mononucleosis and glandular fever.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MCD	Antigen, Ebv, Capsid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K924091	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5ccd680b-0882-472f-b92b-58b7b7097063
Public Version Date: July 14, 2025
Public Version Number: 2
DI Record Publish Date: August 29, 2023