UDI device identifier
AUTION MAX™ AX-4060 Analyzer 100526
UDI device identifier 00015482104658 · Arkray USA, Inc.
Key facts
| Primary DI | 00015482104658 |
|---|---|
| Brand name | AUTION MAX™ AX-4060 Analyzer |
| Version or model | 100526 |
| Company | Arkray USA, Inc. |
| DUNS number | 008171162 |
| Product code | JIL |
| GMDN term | Urine analyser IVD, laboratory |
| Premarket submission | K193514 |
| Device class | Class II |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Nov 7, 2025 |
| Version date | Aug 24, 2026 |
| Description | The AUTION MAX AX-4060 urine analyzer, when used with AUTION Sticks 9EB test strips is a fully automated urinalysis system intended for the in vitro qualitative or semi-quantitative measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite… |
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: