Duns Number:328712260
Device Description: MassCheck® Cortisol, Cortisone, Saliva Control Level II
Catalog Number
0350
Brand Name
Saliva Control
Version/Model Number
0350
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
April 01, 2023
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
-
Prescription Use (Rx)
-
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
4e6530a6-1e89-45f4-9bb3-44463472d0ce
Public Version Date
June 15, 2022
Public Version Number
2
DI Record Publish Date
August 06, 2020
Package DI Number
04250317540447
Quantity per Package
5
Contains DI Package
04250317543158
Package Discontinue Date
April 01, 2023
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 455 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 92 |