Duns Number:687910463
Device Description: It is used for the quantitative measurement of 25-hydroxy vitamin D and related hydroxylat It is used for the quantitative measurement of 25-hydroxy vitamin D and related hydroxylated metabolites in humna serum and plasma.
Catalog Number
FRVDAP 020
Brand Name
FREND
Version/Model Number
FRVD-AP
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K162754
Product Code
MRG
Product Code Name
System, Test, Vitamin D
Public Device Record Key
2cd1bbce-f7b7-4e9d-9c22-cf6192fe423d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 27, 2017
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 | 21 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |