Duns Number:962385787
Device Description: BUN (Blood Urea Nitrogen) 3 x 300 tests
Catalog Number
AU-252
Brand Name
CAROLINA LIQUID CHEMISTRIES CORP.® BUN RGT. KIT AU-252
Version/Model Number
AU-252
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CDQ
Product Code Name
UREASE AND GLUTAMIC DEHYDROGENASE, UREA NITROGEN
Public Device Record Key
e1fd51a3-b4dd-44ee-bdca-56829a910118
Public Version Date
April 17, 2018
Public Version Number
3
DI Record Publish Date
September 01, 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 | 144 |
2 | A medical device with a moderate to high risk that requires special controls. | 183 |
U | Unclassified | 7 |