Duns Number:730958121
Device Description: The Gentian Cystatin C Controls are intended to be used to evaluate the quality of the cal The Gentian Cystatin C Controls are intended to be used to evaluate the quality of the calibration curve established from Gentian Cystatin C Calibrator with the Gentian Cystatin C Immunoassay.
Catalog Number
-
Brand Name
Gentian Cystatin C Single Use Control Low
Version/Model Number
1029
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K071388
Product Code
NDY
Product Code Name
Test, Cystatin C
Public Device Record Key
2bfcbd05-afa0-4a4e-bcc8-3cf6414cc125
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 18, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |