Duns Number:080953946
Device Description: The ZEUS ELISA Mumps IgG Test System is intended for the qualitative detection of Mumps Ig The ZEUS ELISA Mumps IgG Test System is intended for the qualitative detection of Mumps IgG antibody in human sera. 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 Mumps infections.
Catalog Number
SM9Z9281G
Brand Name
ELISA Mumps IgG Smart Kit Test System
Version/Model Number
SM9Z9281G
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
b1377d9f-87a0-45d1-b5bf-ad21855f0317
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 |