Duns Number:075150847
Device Description: For the quantitative determination of thyroid stimulating hormone (TSH) concentration in h For the quantitative determination of thyroid stimulating hormone (TSH) concentration in human serum. The assay is useful in the diagnosis of thyroid or pituitary disorders.
Catalog Number
EIA-1782
Brand Name
Thyroid Stimulating Hormone (TSH) ELISA
Version/Model Number
EIA-1782
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K991146
Product Code
JLW
Product Code Name
RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
Public Device Record Key
f4c9d754-18c2-460c-81a0-5eefe49dfcb0
Public Version Date
March 30, 2020
Public Version Number
2
DI Record Publish Date
March 20, 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 |