AccessGUDID - DEVICE: Gold Standard Diagnostics Is-EBV-EA-D IgG Test Kit (B3507206400)

GUDID

Device Identifier (DI) Information

Brand Name: Gold Standard Diagnostics Is-EBV-EA-D IgG Test Kit
Version or Model: 720-640
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 720-640
Company Name: Gold Standard Diagnostics Corporation

Primary DI Number: B3507206400
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790524891 *Terms of Use

Device Description: Gold Standard Diagnostics Is-EBV-EA-D IgG Test Kit

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:	No
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?
49657	Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to 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
GNP	Antiserum, Cf, Epstein-Barr Virus

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K981831	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: 232aa359-5cc6-47ca-a7c1-5318125ad4be
Public Version Date: December 15, 2022
Public Version Number: 1
DI Record Publish Date: December 07, 2022