Duns Number:790524891
Device Description: ImmunoSimplicity (Is) Mumps IgG ELISA Test Kit is for the qualitative and semi-quantitativ ImmunoSimplicity (Is) Mumps IgG ELISA Test Kit is for the qualitative and semi-quantitative determination of IgG antibodies to Mumps virus in human serum of adults over eighteen years of age by indirect enzyme immunoassay as an aid in the diagnosis of Mimps infection.
Catalog Number
720-540
Brand Name
Gold Standard Diagnostics Is-Mumps IgG ELISA Test Kit
Version/Model Number
720-540
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K991274
Product Code
LJY
Product Code Name
Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Public Device Record Key
4ef2d90f-76b0-4176-b87a-5318f6223a12
Public Version Date
June 04, 2021
Public Version Number
2
DI Record Publish Date
July 27, 2020
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 | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 25 |