Duns Number:829978451
Device Description: MORE DIAGNOSTICS Mycophenolic Acid Control is intended to be used as an assayed control pr MORE DIAGNOSTICS Mycophenolic Acid Control is intended to be used as an assayed control product in monitoring accuracy and precision for quantitative methods that measure mycophenolic acid.
Catalog Number
240
Brand Name
MPA Control
Version/Model Number
240
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
K072257
Product Code
LAS
Product Code Name
Drug Specific Control Materials
Public Device Record Key
5cac8e7e-5fa2-4e8a-b646-b1c30835b02f
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
April 05, 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 |