Duns Number:829978451
Device Description: MORE DIAGNOSTICS Ev/Tac/CsA CONTROL is intended to be used as a whole blood precision cont MORE DIAGNOSTICS Ev/Tac/CsA CONTROL is intended to be used as a whole blood precision control product for the measurement of everolimus, tacrolimus, and cyclosporine.
Catalog Number
305-2
Brand Name
EV/TAC/CsA Control
Version/Model Number
305-2
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
-
Product Code
JJY
Product Code Name
Multi-Analyte Controls, All Kinds (Assayed)
Public Device Record Key
896047b4-abcd-42ba-9d83-ad926d40e06f
Public Version Date
August 14, 2019
Public Version Number
1
DI Record Publish Date
August 06, 2019
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 |