Duns Number:075150847
Device Description: This Triiodothyronine (T3) ELISA is intended for the quantitative determination of triiodo This Triiodothyronine (T3) ELISA is intended for the quantitative determination of triiodothyronine (T3) concentration inhuman serum. This test is useful in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.
Catalog Number
EIA-1780
Brand Name
Triiodothyronine (T3) ELISA
Version/Model Number
EIA-1780
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
K991311
Product Code
CDP
Product Code Name
RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE
Public Device Record Key
f0b0c469-cd1d-4e84-9220-32b38bd51d54
Public Version Date
June 15, 2021
Public Version Number
1
DI Record Publish Date
June 07, 2021
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |