Duns Number:540156544
Device Description: Time-resolved fluoroimmunoassay for the quantitative determination of unconjugated estriol Time-resolved fluoroimmunoassay for the quantitative determination of unconjugated estriol (uE3).
Catalog Number
B095-112
Brand Name
AutoDELFIA Unconjugated Estriol (uE3) kit
Version/Model Number
B095-112
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
CGI
Product Code Name
Radioimmunoassay, Estriol
Public Device Record Key
e4c988d9-14c6-442b-97af-00a995cf70a4
Public Version Date
December 17, 2018
Public Version Number
1
DI Record Publish Date
November 16, 2018
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 | 57 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |
| 3 | A medical device with high risk that requires premarket approval | 2 |