UDI device identifier
AUTION™ MAX AX-4030 Analyzer 14505
UDI device identifier 00015482145057 · Arkray USA, Inc.
Key facts
| Primary DI | 00015482145057 |
|---|---|
| Brand name | AUTION™ MAX AX-4030 Analyzer |
| Version or model | 14505 |
| Company | Arkray USA, Inc. |
| DUNS number | 008171162 |
| Product code | KQO |
| GMDN term | Urine analyser IVD, laboratory |
| Premarket submission | K093098 |
| Device class | Class I |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Sep 23, 2016 |
| Version date | Aug 24, 2026 |
| Description | 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. |
At a glance
- None MAUDE reports citing this UDI
- Yes Linked premarket submission
- No EUDAMED counterpart found
- 10–99 GUDID devices with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About UDI device identifiers (GUDID)
The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.
Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date: