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 C-reactive protein (CRP).
Catalog Number
K80C-4M
Brand Name
K-ASSAY® hs-CRP Control
Version/Model Number
K80C-4M
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 18, 2021
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
K022486
Product Code
DCK
Product Code Name
C-Reactive Protein, Antigen, Antiserum, And Control
Public Device Record Key
e2e5b504-b161-452e-a560-7eed9dd1c75b
Public Version Date
June 10, 2022
Public Version Number
5
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 |