Duns Number:784143778
Device Description: For the quantitative determination of total estrogens by an enzyme immunoassay in human se For the quantitative determination of total estrogens by an enzyme immunoassay in human serum.
Catalog Number
11-ESGTHU-E01
Brand Name
Total Estrogens ELISA
Version/Model Number
11-ESGTHU-E01
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
JMD
Product Code Name
Radioimmunoassay, Total Estrogens, Nonpregnancy
Public Device Record Key
5cf1e052-0aa8-432d-9d92-bebd650b57ba
Public Version Date
September 19, 2022
Public Version Number
1
DI Record Publish Date
September 09, 2022
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 | 42 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |