Duns Number:080953946
Device Description: The ZEUS IFA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM Test System is a pre-st The ZEUS IFA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM Test System is a pre-standardized test system designed for the qualitative and semi-quantitative detection of EBV-VCA IgM antibodies in human serum by the indirect fluorescent antibody (IFA) technique, and is for In Vitro diagnostic use.
Catalog Number
FA9151M
Brand Name
IFA EBV-VCA IgM Test System
Version/Model Number
FA9151M
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
f9e00ebe-ee21-448f-a652-e67f2e44755b
Public Version Date
February 21, 2019
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |