Duns Number:829978451
Device Description: MORE DIAGNOSTICS Cyclosporine C2 Controls are assayed quality control materials for monito MORE DIAGNOSTICS Cyclosporine C2 Controls are assayed quality control materials for monitoring and evaluating precision and accuracy of quantitative cyclosporine measurements in whole blood.
Catalog Number
202
Brand Name
Cyclosporine C2 Control
Version/Model Number
202
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
K932662
Product Code
LAS
Product Code Name
Drug Specific Control Materials
Public Device Record Key
56c07116-5c84-48aa-98de-5d257a0fe0d0
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
April 03, 2018
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 | 28 |