Duns Number:687769737
Device Description: The URiSCAN Optima urine chemistry test system consists of URiSCAN Optima Urine analyzer a The URiSCAN Optima urine chemistry test system consists of URiSCAN Optima Urine analyzer and URiSCAN urine test strips. The intended use of the URiSCAN Optima Urine analyzer is to read the color change on the test pads found on the URiSCAN urine test strips and to display and print the results. These measurements are useful in the evaluation of renal, urinary and metabolic disorders.
Catalog Number
-
Brand Name
URiSCAN Optima
Version/Model Number
Optima
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"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K141874
Product Code
KQO
Product Code Name
Automated Urinalysis System
Public Device Record Key
760c5dbf-d88f-41da-92b2-ce3b2770a1b6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 05, 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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |