Duns Number:207718438
Device Description: TRIIODOTHYRONINE (T3) ELISA KIT FOR THE QUANTITATIVE MEASUREMENT OF TRIIODOTHYRONINE IN HU TRIIODOTHYRONINE (T3) ELISA KIT FOR THE QUANTITATIVE MEASUREMENT OF TRIIODOTHYRONINE IN HUMAN SERUM
Catalog Number
CAN-T3-4220
Brand Name
NA
Version/Model Number
CAN-T3-4220
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
CDP
Product Code Name
Radioimmunoassay, Total Triiodothyronine
Public Device Record Key
c9d9f869-2664-4557-a716-c44e2d0b4ff8
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 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. | 1 |