Duns Number:276816717
Device Description: VIDAS ® Estradiol II (E2 II) assay is a quantitative IA intended for use on VIDAS family i VIDAS ® Estradiol II (E2 II) assay is a quantitative IA intended for use on VIDAS family instrument in the detection of total estradiol concentration in human serum or plasma.
Catalog Number
-
Brand Name
VIDAS® Estradiol II
Version/Model Number
30431-01
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
K955647
Product Code
CHP
Product Code Name
RADIOIMMUNOASSAY, ESTRADIOL
Public Device Record Key
73643322-44c4-4f35-9ba2-2dc5bcbb84ee
Public Version Date
October 11, 2019
Public Version Number
1
DI Record Publish Date
October 03, 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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 156 |
| 3 | A medical device with high risk that requires premarket approval | 3 |