Duns Number:540156544
Device Description: Time-resolved fluoroimmunoassay for the quantitative determination of thyroxine (T4) in dr Time-resolved fluoroimmunoassay for the quantitative determination of thyroxine (T4) in dried blood.
Catalog Number
A065-110
Brand Name
DELFIA Neonatal Thyroxine (T4) kit
Version/Model Number
A065-110
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
CDX
Product Code Name
Radioimmunoassay, Total Thyroxine
Public Device Record Key
94d0c42e-7a63-4596-af7b-007b3f5fb0d3
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
February 02, 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 | 57 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |
| 3 | A medical device with high risk that requires premarket approval | 2 |