Duns Number:328712260
Device Description: MassCheck® 25-OH-Vitamin D3/D2 and 3-epi-25-OH-Vitamin D3 Serum Control Level II
Catalog Number
0312
Brand Name
Serum Control
Version/Model Number
0312
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)
-
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
f67b29dd-749c-4e58-a782-08fbc390eab2
Public Version Date
September 29, 2022
Public Version Number
2
DI Record Publish Date
August 06, 2020
Package DI Number
04250317524959
Quantity per Package
5
Contains DI Package
04250317545480
Package Discontinue Date
-
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 |