Duns Number:010717890
Device Description: The Complete D 25-OH Vitamin D control is intended to monitor the performance of clinical The Complete D 25-OH Vitamin D control is intended to monitor the performance of clinical assays used to quantitate total 25-OH Vitamin D. It is supplied in two levels, 3mL per vial. Each kit contains 2 vials of level 1 and 2 vials of level 2 controls. The controls are liquid, ready to use and require no reconstitution of dilution. The controls are prepared in a human serum matrix fortified with analytes and preservatives. This control contains both 25-OH Vitamin D2 and D3, and when combined represent clinically relevant levels of Total Vitamin D.
Catalog Number
1290-01
Brand Name
Complete D 25-OH Vitamin Control Level 1&2 Set 4x3mL
Version/Model Number
1290-01
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
K113177
Product Code
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
af0feafe-ccc4-45f5-95e0-5c2414c2ecff
Public Version Date
October 29, 2018
Public Version Number
1
DI Record Publish Date
September 26, 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 | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |