Duns Number:784143778
Device Description: The Total Estrogens ELISA is for the direct quantitative determination of total estrogens The Total Estrogens ELISA is for the direct quantitative determination of total estrogens (estrone, estradiol, and estriol) in human serum by enzyme immunoassay. For in vitro diagnostic use.
Catalog Number
11-ESTTHU-E01
Brand Name
Total Estrogens ELISA
Version/Model Number
11-ESTTHU-E01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 04, 2021
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
a2fcfac1-8050-4501-ab40-2e579bc63f01
Public Version Date
August 31, 2022
Public Version Number
2
DI Record Publish Date
September 25, 2020
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 |