Duns Number:045623154
Device Description: Free T4 for the quantitative determination of Free Thyroxine (fT4) concentration in human Free T4 for the quantitative determination of Free Thyroxine (fT4) concentration in human serum. FOR RESEARCH USE ONLY. NOT FOR USE IN DIAGNOSTIC PROCEDURES. 96 Tests.
Catalog Number
T1008-96
Brand Name
Pointe Scientific, Inc.
Version/Model Number
T1008-96
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K020548
Product Code
CEC
Product Code Name
Radioimmunoassay, Free Thyroxine
Public Device Record Key
6cf6c983-4f7f-4f3e-9fd5-442c26b7ad6f
Public Version Date
July 06, 2018
Public Version Number
3
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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 455 |
| U | Unclassified | 2 |