Duns Number:878252071
Device Description: AccuDiag ™ Herpes Simplex Virus (HSV) 1 & 2 IgM ELISA is an enzyme-linked immunosorbent as AccuDiag ™ Herpes Simplex Virus (HSV) 1 & 2 IgM ELISA is an enzyme-linked immunosorbent assay for the qualitative detection of IgM class antibodies to Herpes Simplex Virus (HSV) in human serum. This test is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV and is for In Vitro diagnostic use.
Catalog Number
1444-2
Brand Name
AccuDiag ™
Version/Model Number
DACD 1444-2
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"
-
For Single-Use
Yes
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
LGC
Product Code Name
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Public Device Record Key
9b32b834-fdb9-435f-8cee-9a5f2b0202e8
Public Version Date
August 18, 2021
Public Version Number
1
DI Record Publish Date
August 10, 2021
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |