Duns Number:829978451
Device Description: MORE DIAGNOSTICS Rap/Tac/CsA CONTROL is intended to be used as a whole blood precision con MORE DIAGNOSTICS Rap/Tac/CsA CONTROL is intended to be used as a whole blood precision control product for the measurement of rapamycin, tacrolimus, and cyclosporine.
Catalog Number
290-3
Brand Name
Rap/Tac/CsA Control
Version/Model Number
290-3
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
K050125
Product Code
JJY
Product Code Name
Multi-Analyte Controls, All Kinds (Assayed)
Public Device Record Key
a9722ec1-34e3-4d11-a5f2-7018a4f5c627
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
March 31, 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 |