Duns Number:064608573
Device Description: VERSANT HCV Amplification 2.0 Kit (LiPA) 100 Test for HCV genotyping
Catalog Number
10719667
Brand Name
VERSANT HCV 2.0 LiPA
Version/Model Number
10719667
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
P160016
Product Code
OBF
Product Code Name
Assay, genotyping, hepatitis c virus
Public Device Record Key
47577d72-b851-4bad-87c0-b3dc710fc0c9
Public Version Date
November 19, 2021
Public Version Number
5
DI Record Publish Date
September 15, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 363 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 829 |
| 3 | A medical device with high risk that requires premarket approval | 57 |
| U | Unclassified | 7 |