Duns Number:790524891
Device Description: ImmunoSimplicity (Is) EBNA-1 IgM ELISA Test Kit for the qualitative determination of IgM a ImmunoSimplicity (Is) EBNA-1 IgM ELISA Test Kit for the qualitative determination of IgM antibodies to Epstein-Bar Virus Nuclear Antigen-1 (EBNA-1 IgM) in human serum by indirect enzyme immunoassay.
Catalog Number
720-630
Brand Name
Gold Standard Diagnostics Is-EBNA-1 IgM ELISA Test Kit
Version/Model Number
720-630
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
K982348
Product Code
LSE
Product Code Name
Epstein-Barr Virus, Other
Public Device Record Key
6143d0bd-8e6c-44cb-b27c-21fa58ccafe3
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 |