Duns Number:137825928
Device Description: Radioimmunoassay for the quantitative determination of Aldosterone in human plasma or seru Radioimmunoassay for the quantitative determination of Aldosterone in human plasma or serum.
Catalog Number
07108202
Brand Name
Aldosterone Double Antibody 125I RIA Kit
Version/Model Number
07108202
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
K862204
Product Code
CJM
Product Code Name
RADIOIMMUNOASSAY, ALDOSTERONE
Public Device Record Key
f61770e1-e2f8-4085-977f-fb95607844da
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 20, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |