Duns Number:008171162
Device Description: Urine Analyzer utilize reflectance technology with with AUTION Strips reagent to provide Urine Analyzer utilize reflectance technology with with AUTION Strips reagent to provide qualitative or semiquantitative urine chemistry results. Refractometery is used for specific gravity measurements, light transmission for color, and light scatter for turbidity.
Catalog Number
-
Brand Name
AUTION™ MAX AX-4022 Analyzer
Version/Model Number
102974
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K160062
Product Code
CDM
Product Code Name
DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)
Public Device Record Key
d5aeb679-7a4a-4156-a083-276cb8310d43
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 03, 2017
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 | 30 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |