Duns Number:137825928
Device Description: Radioimmunoassay for the quantitative determination of Total Thyroxine (T4) MAb in human p Radioimmunoassay for the quantitative determination of Total Thyroxine (T4) MAb in human plasma or serum.
Catalog Number
06B254011
Brand Name
Total T4 MAb 125I RIA Kit
Version/Model Number
06B254011
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
K904816
Product Code
CDX
Product Code Name
Radioimmunoassay, total thyroxine
Public Device Record Key
5c926659-8664-45a7-94b0-05863f5e6c23
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 20, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |