Duns Number:276816717
Device Description: The VIDAS ® T4 (T4) assay is intended for use on the VIDAS instruments for the determinat The VIDAS ® T4 (T4) assay is intended for use on the VIDAS instruments for the determinat ion of human thyroxine (T4) concentration in serum or plasma (heparin).
Catalog Number
-
Brand Name
VIDAS® T4
Version/Model Number
30404-01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 07, 2022
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
K141133,K926393
Product Code
KLI
Product Code Name
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Public Device Record Key
63c8e847-2e05-4869-8b1d-7c9678ad70d7
Public Version Date
September 27, 2022
Public Version Number
5
DI Record Publish Date
August 31, 2016
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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 156 |
| 3 | A medical device with high risk that requires premarket approval | 3 |