Duns Number:080953946
Device Description: The ZEUS ELISA Varicella-Zoster Virus (VZV) IgG Test System is intended for the qualitativ The ZEUS ELISA Varicella-Zoster Virus (VZV) IgG Test System is intended for the qualitative detection of VZV IgG antibody in human serum. When performed according to these instructions, the results of this test, together with other clinical information, may aid in the determination of immune status, and/or aid in the diagnosis of VZV infections. This test is intended for In Vitro diagnostic use.
Catalog Number
Q9Z9331GB
Brand Name
ELISA VZV IgG Q Test System
Version/Model Number
Q9Z9331GB
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
daa0131d-8021-434e-b264-1febe22dd4a9
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 |