Duns Number:540481217
Device Description: It is used to confirm that your Blood Uric Acid Test Strips and Multi-Monitoring Meter are It is used to confirm that your Blood Uric Acid Test Strips and Multi-Monitoring Meter are working together properly and that you are performing the test correctly.
Catalog Number
-
Brand Name
Uric Acid Control solution(level 1)
Version/Model Number
CM311
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LFQ
Product Code Name
Acid, Uric, Acid Reduction Of Ferric Ion
Public Device Record Key
493436f5-a2e1-486a-92e1-3ba9cfd00e1a
Public Version Date
May 25, 2022
Public Version Number
1
DI Record Publish Date
May 17, 2022
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 | 5 |