Duns Number:045623154
Device Description: Pointe BUN Reagent packaged for use on the Mindray BA800. 7 x 66ml R1, 3 x 43ml R2. For Pointe BUN Reagent packaged for use on the Mindray BA800. 7 x 66ml R1, 3 x 43ml R2. For the quantitative determination of urea nitrogen in serum. For in vitro diagnostic use only.
Catalog Number
16-B7552-591
Brand Name
Pointe BUN Reagent
Version/Model Number
16-B7552-591
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
88d4bf07-4a18-4afe-b0d7-e91d8f0b770f
Public Version Date
February 08, 2021
Public Version Number
1
DI Record Publish Date
January 30, 2021
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 |