Duns Number:008675485
Device Description: digene® HC2 HPV DNA Test (Low-Risk HPV and High-Risk HPV)
Catalog Number
5198-1220
Brand Name
hc2 HPV DNA Test
Version/Model Number
1
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
-
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
P890064
Product Code
MAQ
Product Code Name
Kit, Dna Detection, Human Papillomavirus
Public Device Record Key
4d4c78d4-77eb-44c9-bda8-3d030eae6469
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 04, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |
| 3 | A medical device with high risk that requires premarket approval | 11 |