Duns Number:045623154
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.
Catalog Number
12-B7552-150
Brand Name
POINTE SCIENTIFIC BUN
Version/Model Number
12-B7552-150
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
K972671
Product Code
CDQ
Product Code Name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
Public Device Record Key
bfa6c6b3-d3f7-40e1-bc52-c6c34f7d4b26
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
August 31, 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 | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 455 |
| U | Unclassified | 2 |