Duns Number:126544316
Device Description: An in vitro diagnostic test for the determination of vitamin D in human serum and plasma s An in vitro diagnostic test for the determination of vitamin D in human serum and plasma specimen.
Catalog Number
TF8148
Brand Name
Fluoro-CheckTM Vitamin D
Version/Model Number
TF8148
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MRG
Product Code Name
System, Test, Vitamin D
Public Device Record Key
6e59cc69-d909-4cb5-944b-78878cebd88f
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
May 24, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-