Duns Number:075150847
Device Description: The Mumps Virus IgG ELISA is intended for the qualitative determination of IgG class antib The Mumps Virus IgG ELISA is intended for the qualitative determination of IgG class antibodies against Mumps Virus in human serum or plasma (citrate, heparin).
Catalog Number
EIA-3846
Brand Name
Mumps Virus IgG ELISA
Version/Model Number
EIA-3846
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LJY
Product Code Name
ENZYME LINKED IMMUNOABSORBENT ASSAY, MUMPS VIRUS
Public Device Record Key
6b4f3c4a-b2bb-4aa9-ab4c-a1d5c7ab7881
Public Version Date
August 09, 2021
Public Version Number
3
DI Record Publish Date
March 20, 2019
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |