Duns Number:962385787
Device Description: Uric Acid (URIC) Reagent
Catalog Number
ST212
Brand Name
CAROLINA LIQUID CHEMISTRIES CORP.® URIC ACID REAGENT KIT ST212
Version/Model Number
ST212
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
-
Product Code
KNK
Product Code Name
Acid, uric, uricase (colorimetric)
Public Device Record Key
494758de-2c19-4fb9-b1e2-013f5fa1b0ac
Public Version Date
August 29, 2022
Public Version Number
1
DI Record Publish Date
August 19, 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 | 144 |
2 | A medical device with a moderate to high risk that requires special controls. | 183 |
U | Unclassified | 7 |