Duns Number:075150847
Device Description: For the quantitative determination of Estrone in human saliva by a chemiluminescence immun For the quantitative determination of Estrone in human saliva by a chemiluminescence immunoassay.
Catalog Number
CLA-4654
Brand Name
Estrone Serum ELISA
Version/Model Number
CLA-4654
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
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
CGF
Product Code Name
RADIOIMMUNOASSAY, ESTRONE
Public Device Record Key
ecbe75f3-ae55-434d-ad60-e94c34509f58
Public Version Date
December 22, 2021
Public Version Number
2
DI Record Publish Date
June 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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |