Duns Number:797393659
Device Description: 10-Parameter Urine Reagent Strip For Use with Accustrip URS ReaderBlood, Urobilinogen, Bil 10-Parameter Urine Reagent Strip For Use with Accustrip URS ReaderBlood, Urobilinogen, Billirubin, Protein, Nitrite, Ketone, Glucose, pH, SG, Leukocytes
Catalog Number
00763924870103
Brand Name
Accustrip 10-Parameter Urine Reagent Strip
Version/Model Number
UA870
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
K991927,K991927
Product Code
CDM
Product Code Name
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
Public Device Record Key
96a68ff2-0fb2-4e65-a17e-3f04a751b86c
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 |