Duns Number:261769626
Device Description: Radioimmunometric assay kit for the quantitative determination of active renin in human pl Radioimmunometric assay kit for the quantitative determination of active renin in human plasma.Contains enough reagents for 100 tests. For in vitro diagnostic.Quantitative determination of active renin is used in the diagnostic and treatment of certain types of hypertensions.
Catalog Number
RENIN
Brand Name
ACTIVE RENIN
Version/Model Number
RENIN
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 06, 2021
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)
Yes
FDA Premarket Submission
K062120
Product Code
CIB
Product Code Name
Radioimmunoassay, Angiotensin I And Renin
Public Device Record Key
84b11076-e43d-4eb7-891c-b26db17ef93b
Public Version Date
December 08, 2021
Public Version Number
4
DI Record Publish Date
August 08, 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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |