Duns Number:790524891
Device Description: ImmunoSimplicity (Is) HSV 1&2 IgG Test for the detection of IgG antibodies to herpes simpl ImmunoSimplicity (Is) HSV 1&2 IgG Test for the detection of IgG 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
720-340
Brand Name
Gold Standard Diagnostics Is-HSV 1&2 IgG ELISA Test Kit
Version/Model Number
720-340
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
-
Product Code
LGC
Product Code Name
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Public Device Record Key
6227b622-6798-42fe-aaa3-b29bd75b0748
Public Version Date
June 04, 2021
Public Version Number
2
DI Record Publish Date
August 28, 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 |