Duns Number:540096708
Device Description: The Cascadion™ SM 25-Hydroxy Vitamin D Assay is for the determination of total 25-Hydroxy
Catalog Number
10026927
Brand Name
Cascadion™ SM 25-Hydroxy Vitamin D Calibrator Set
Version/Model Number
NONE
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
-
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
PSL
Product Code Name
25-Oh-Vitamin D Mass Spectrometry Test System
Public Device Record Key
e7baf2ba-021e-4b7b-853c-cf8383602c7b
Public Version Date
March 10, 2020
Public Version Number
1
DI Record Publish Date
March 02, 2020
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |