AccessGUDID - DEVICE: EBV-VCA IgG Test System, 120 Tests (B110EBG1200)

GUDID

Device Identifier (DI) Information

Brand Name: EBV-VCA IgG Test System, 120 Tests
Version or Model: EBG-120
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EBG-120
Company Name: Bion Enterprises, Ltd.

Primary DI Number: B110EBG1200
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 024824641 *Terms of Use

Device Description: No description.

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:	No
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?
49658	Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay	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 a fluorescent immunoassay 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
JRY	Antiserum, Fluorescent, Epstein-Barr Virus

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K891785	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: f359c8b6-97dc-48bd-b855-84fba969b0f1
Public Version Date: March 04, 2020
Public Version Number: 5
DI Record Publish Date: September 12, 2016