Duns Number:197934250
Device Description: For use as a consistent test sample of known concentration for monitoring assay conditions For use as a consistent test sample of known concentration for monitoring assay conditions for D-Dimer.
Catalog Number
K92C-4M
Brand Name
K-ASSAY® D-Dimer Control
Version/Model Number
K92C-4M
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
-
Product Code
GGN
Product Code Name
Plasma, Coagulation Control
Public Device Record Key
55b4bc2e-8062-40c8-b842-2ba71e1770bc
Public Version Date
July 02, 2018
Public Version Number
1
DI Record Publish Date
May 30, 2018
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 | 49 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 66 |