Duns Number:797393659
Device Description: Accustrip URS 10 parameter Strips and Accustrip URS Reader
Catalog Number
-
Brand Name
Accustrip URS Strips + Reader
Version/Model Number
UA897
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K061742,K991927,K991927,K061742
Product Code
CDM
Product Code Name
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
Public Device Record Key
f0907d67-92ec-4cbe-afea-d17386dffbfd
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |