AccessGUDID - DEVICE: Epstein-Barr Virus (VCA) Antigen Substrate, 12 wells, For IFA Test System (B110EB50120)

GUDID

Device Identifier (DI) Information

Brand Name: Epstein-Barr Virus (VCA) Antigen Substrate, 12 wells, For IFA Test System
Version or Model: EB-5012
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EB-5012
Company Name: Bion Enterprises, Ltd.

Primary DI Number: B110EB50120
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:	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?
49667	Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to Epstein-Barr virus (EBV) in a clinical specimen.	Active	false
49661	Epstein-Barr virus (EBV) immunoglobulin G (IgG) antibody IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Epstein-Barr virus (EBV) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LJN	Antibody Igm, If, Epstein-Barr Virus

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K893240	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: less than 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 60d56b77-07be-4309-a58d-426977bbdef8
Public Version Date: March 04, 2020
Public Version Number: 5
DI Record Publish Date: September 12, 2016