Duns Number:961027315
Device Description: Urinalysis Analyzer KitFor UrineContains:1 - Semi-Atuo Urine Analyzer6 - Bottles of UA10SG Urinalysis Analyzer KitFor UrineContains:1 - Semi-Atuo Urine Analyzer6 - Bottles of UA10SGL StripsX1UAREADER1
Catalog Number
UAREADER1
Brand Name
CARDINAL HEALTH
Version/Model Number
UAREADER1
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CDM
Product Code Name
DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)
Public Device Record Key
fbce4e77-5f56-4e55-a34f-5de74bcabfe7
Public Version Date
December 22, 2021
Public Version Number
3
DI Record Publish Date
July 09, 2020
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |