Duns Number:197934250
Device Description: For the quantitative determination of human cystatin C in serum, EDTA plasma, or lithium h For the quantitative determination of human cystatin C in serum, EDTA plasma, or lithium heparin plasma by immunoturbidimetric assay.
Catalog Number
KAI-073
Brand Name
K-ASSAY® Cystatin C Reagent
Version/Model Number
KAI-073
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 05, 2022
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
K093137
Product Code
NDY
Product Code Name
Test, Cystatin C
Public Device Record Key
6a07322e-a841-432d-a01a-a0cb3ee6efb1
Public Version Date
October 06, 2022
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 |