Duns Number:048144997
Device Description: For the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use For the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only. Determination of urea nitrogen in serum is widely used as a screening test for renal function. When used in conjunction with the determination of creatinine in serum it is helpful in the differential diagnosis of the three types of azotemia; pre-renal, renal and post-renal.
Catalog Number
501-404
Brand Name
Urea Nitrogen Reagent Set
Version/Model Number
R1 x 500mL, R2 x 125mL
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CDQ
Product Code Name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
Public Device Record Key
cd02d486-6d52-4069-838f-b22f3c491a63
Public Version Date
April 17, 2018
Public Version Number
3
DI Record Publish Date
October 12, 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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |