Duns Number:075150847
Device Description: The Quantitative Determination of Thyrotropin Concentration in Human Serum by a Microplate The Quantitative Determination of Thyrotropin Concentration in Human Serum by a Microplate Immunoenzymometric assay.
Catalog Number
EIA-4111
Brand Name
Thyrotropin (TSH) ELISA
Version/Model Number
EIA-4111
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
K971780
Product Code
JLW
Product Code Name
RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
Public Device Record Key
deaca85e-a04c-46dc-ae41-4df9ad1bdf74
Public Version Date
March 30, 2020
Public Version Number
2
DI Record Publish Date
June 10, 2019
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 |