Duns Number:008254708
Device Description: Radioimmunoassay Kit for the quantitative measurement of aldosterone in human serum, plasm Radioimmunoassay Kit for the quantitative measurement of aldosterone in human serum, plasma or urine.
Catalog Number
DSL8600
Brand Name
ACTIVE Aldosterone RIA
Version/Model Number
DSL8600
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
CJM
Product Code Name
Radioimmunoassay, Aldosterone
Public Device Record Key
9d2fe13b-ded0-4b6a-8acf-4d736b7460d5
Public Version Date
December 05, 2019
Public Version Number
3
DI Record Publish Date
September 09, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 319 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 503 |
| 3 | A medical device with high risk that requires premarket approval | 9 |
| U | Unclassified | 1 |