Duns Number:878263359
Device Description: Abbott RealTime HCV Genotype II Control Kit
Catalog Number
08L21-80
Brand Name
RealTime
Version/Model Number
08L21-80
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
P120012,P120012,P120012,P120012,P120012,P120012,P120012,P120012,P120012,P120012,P120012,P120012,P120012,P120012,P120012,P120012,P120012
Product Code
OBF
Product Code Name
Assay, genotyping, hepatitis c virus
Public Device Record Key
f383a96e-76ef-4129-b6c5-fd1eb30f3fb3
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
November 20, 2014
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 | 339 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |
| 3 | A medical device with high risk that requires premarket approval | 36 |