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 the listed constituents.
Catalog Number
K81C-6M
Brand Name
K-ASSAY® Plasma Control
Version/Model Number
K81C-6M
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 26, 2019
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
GGC
Product Code Name
Control, Plasma, Abnormal
Public Device Record Key
4e2a4b7d-3830-4d67-94dc-9259670eba17
Public Version Date
December 27, 2019
Public Version Number
4
DI Record Publish Date
September 16, 2016
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 |