Duns Number:048144997
Device Description: For the quantitative determination of Uric Acid in serum. For in vitro diagnostic use onl For the quantitative determination of Uric Acid in serum. For in vitro diagnostic use only. The determination of uric acid in serum is most commonly performed for the diagnosis of gout. Increased uric acid levels are also found in leukemia, polycythemia, familial idiopathic hyperuricemia, and conditions associated with decreased renal function.
Catalog Number
501-418
Brand Name
Uric Acid Reagent
Version/Model Number
500mL
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KNK
Product Code Name
Acid, Uric, Uricase (Colorimetric)
Public Device Record Key
b88337ce-f3a8-4957-ae2c-d692d35c2b8a
Public Version Date
March 29, 2018
Public Version Number
2
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 |