Duns Number:045623154
Device Description: Uric Acid Standard intended for use as an uric acid standard for standardization or calibr Uric Acid Standard intended for use as an uric acid standard for standardization or calibration of uricase / trinder uric acid procedures.Packaged at 1 x 15ml
Catalog Number
U7580-STD
Brand Name
Pointe Scientific, Inc.
Version/Model Number
U7580-STD
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
K812430
Product Code
KNK
Product Code Name
Acid, Uric, Uricase (Colorimetric)
Public Device Record Key
b4386448-28a4-4d34-a12c-6464b1ff1152
Public Version Date
July 06, 2018
Public Version Number
3
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 |