Duns Number:460055742
Device Description: 20 Test Devices20 x 0,7 ml Sample Diluent20 x 0,5 ml Developing Reagent20 x Empty Vials 12 20 Test Devices20 x 0,7 ml Sample Diluent20 x 0,5 ml Developing Reagent20 x Empty Vials 120 x Pre-filter tips20 x Capillary tubes20 x Lancets20 x Swabs20 x Tube racks
Catalog Number
-
Brand Name
biokitHSV-2
Version/Model Number
300028001
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K983886
Product Code
LGC
Product Code Name
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
Public Device Record Key
7f424a0f-e9cc-4126-bfaa-c5c7a895a1f9
Public Version Date
October 18, 2022
Public Version Number
1
DI Record Publish Date
October 10, 2022
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |