Duns Number:137825928
Device Description: Radioimmunoassay for the quantitative determination of T3 Uptake in serum.
Catalog Number
06B237124
Brand Name
T3 Uptake 125I RIA 200 Tube Kit
Version/Model Number
06B237124
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
-
Product Code
KHQ
Product Code Name
RADIOASSAY, TRIIODOTHYRONINE UPTAKE
Public Device Record Key
b4167808-cfe5-4fe3-9063-4aed068ada62
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 09, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 36 |