Duns Number:790524891
Device Description: ImmunoSimplicity (Is) HSV 1&2 IgM Test for the detection of IgM antibodies to herpes simpl ImmunoSimplicity (Is) HSV 1&2 IgM Test for the detection of IgM antibodies to herpes simplex virus (HSV) type 1 and/or type 2 as an aid in the diagnosis of a primary or reactivated infection with HSV.
Catalog Number
720-350
Brand Name
Gold Standard Diagnostics Is-HSV 1&2 IgM ELISA Test Kit
Version/Model Number
720-350
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
K002262
Product Code
LGC
Product Code Name
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Public Device Record Key
0214fff4-cbe0-4abc-945b-51b7e9126050
Public Version Date
August 12, 2021
Public Version Number
4
DI Record Publish Date
June 03, 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 |