Duns Number:481261006
Device Description: The BÜHLMANN Angiotensin II is a double antibody radioimmunoassay designed for t The BÜHLMANN Angiotensin II is a double antibody radioimmunoassay designed for the quantitative in vitro diagnostic determination of immunoreactive Angiotensin II in extracted EDTA plasma.
Catalog Number
RK-A22
Brand Name
Angiotensin II RIA
Version/Model Number
RK-A22
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 27, 2017
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K954299
Product Code
CIB
Product Code Name
Radioimmunoassay, Angiotensin I And Renin
Public Device Record Key
46385785-b5b3-4175-a282-e7c9e5f16624
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 01, 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. | 8 |