Duns Number:227530649
Device Description: The device is intended to be used for in the calibration of Cystatin C assays.
Catalog Number
CYS2699
Brand Name
CYSC CAL
Version/Model Number
CYS2699
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
K083906
Product Code
JIT
Product Code Name
Calibrator, Secondary
Public Device Record Key
896e8784-6f3d-44bf-a437-f9b0d88181ec
Public Version Date
July 06, 2018
Public Version Number
3
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 | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |