AccessGUDID - DEVICE: IFA EBV-NA IgG Test System (00845533001625)

GUDID

Device Identifier (DI) Information

Brand Name: IFA EBV-NA IgG Test System
Version or Model: FA9153
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FA9153
Company Name: ZEUS SCIENTIFIC, INC.

Primary DI Number: 00845533001625
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080953946 *Terms of Use

Device Description: The ZEUS IFA Epstein-Barr Virus Nuclear Antigen (EBV-NA) anti-complement immunofluorescence (ACIF) Test System is a relatively rapid and sensitive method for the qualitative and semi-quantitative detection of antibodies to the nuclear antigen of Epstein-Barr virus in human sera. When performed according to instructions, this assay can provide information on infectious mononucleosis (IM) that may be of value in patient management and treatment. This device 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):	Yes
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?
49678	Epstein-Barr virus nuclear antigen (EBNA) 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 the Epstein-Barr virus nuclear antigen (EBNA) of 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.	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
Special Storage Condition, Specify: Store G.P. Complement at -20C
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: df0d4e50-06bf-443e-a924-127ec90182b8
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016