Duns Number:080953946
Device Description: The ZEUS ELISA Epstein Barr Virus Early Antigen (EBV-EA) IgG Test System provides a means The ZEUS ELISA Epstein Barr Virus Early Antigen (EBV-EA) IgG Test System provides a means for the qualitative detection of IgG class antibodies to Epstein-Barr Virus (EBV) Early Antigen (EA) in human sera. This test is intended to aid in the diagnosis of infectious mononucleosis (IM) when used with other EBV serological tests. The performance characteristics have not been established to aid in the diagnosis of acute IM. This test is intended for In Vitro diagnostic use only.
Catalog Number
SM9Z9481G
Brand Name
ELISA EBV-EA IgG Smart Kit Test System
Version/Model Number
SM9Z9481G
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
0c90844d-c3bc-405e-a585-76b5f7ef3932
Public Version Date
March 29, 2018
Public Version Number
2
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 |