AccessGUDID - DEVICE: ELISA EBNA-1 IgG Test Sytem (00845533000437)

GUDID

Device Identifier (DI) Information

Brand Name: ELISA EBNA-1 IgG Test Sytem
Version or Model: 9Z9461G
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9Z9461G
Company Name: ZEUS SCIENTIFIC, INC.

Primary DI Number: 00845533000437
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080953946 *Terms of Use

Device Description: The ZEUS ELISA Epstein-Barr Virus Nuclear Antigen-1 (EBNA-1) IgG Test System provides a means for the qualitative detection of IgG antibodies to the nuclear antigen-1 of Epstein-Barr virus (EBNA-1) in human sera. When performed according to these instructions, the results of this test together with other testing, such as the heterophile test, and the EBV-VCA IgG and IgM tests, may aid in the diagnosis of, and provide information on infectious mononucleosis (IM), that may be of value in patient management and treatment. It is for In Vitro diagnostic use.

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?
49677	Epstein-Barr virus nuclear antigen (EBNA) 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 the Epstein-Barr virus nuclear antigen (EBNA) 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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 017ebd68-ed67-47b2-bcf7-ae7d5514c6a7
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016