Duns Number:261769626
Device Description: Radioimmunometric assay kit for the quantitative determination of low levels of estradiol Radioimmunometric assay kit for the quantitative determination of low levels of estradiol in human samples. Contain enough reagents for 100 tests. For in vitro diagnostic.
Catalog Number
ESTR-S-US
Brand Name
ESTR-S-US
Version/Model Number
ESTR-S-US
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
-
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
CHP
Product Code Name
Radioimmunoassay, Estradiol
Public Device Record Key
29e3b89b-9a95-487e-b331-5e40dda9d73f
Public Version Date
December 15, 2021
Public Version Number
1
DI Record Publish Date
December 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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |