Duns Number:119214195
Device Description: Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which several differe Urine Reagent Strips (URS) for Urinalysis are firm plastic strips to which several different reagent areas are affixed
Catalog Number
-
Brand Name
Detector UA 10
Version/Model Number
IDU-10
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
K970250,K970250,K970250
Product Code
CDM
Product Code Name
DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)
Public Device Record Key
736b3984-df71-4c6f-8d91-e4c017de750a
Public Version Date
December 22, 2021
Public Version Number
4
DI Record Publish Date
September 26, 2016
Package DI Number
20722355002204
Quantity per Package
24
Contains DI Package
10722355002221
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |