UDI device identifier
Aution™ Hybrid AU-4050 Chemical Analyzer 14603
UDI device identifier 00015482146030 · Arkray USA, Inc.
Key facts
| Primary DI | 00015482146030 |
|---|---|
| Brand name | Aution™ Hybrid AU-4050 Chemical Analyzer |
| Version or model | 14603 |
| Company | Arkray USA, Inc. |
| DUNS number | 008171162 |
| Product code | KQO |
| GMDN term | Flow cytometry analyser IVD |
| Premarket submission | K121456 |
| Device class | Class I |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Feb 6, 2017 |
| Version date | Aug 24, 2026 |
| Description | he AUTION HYBRID AU-4050 Fully Automated Integrated Urine Analyzer System contains a test strip chemistry urine analyzer and a flow cytometry urine particle analyzer together in a single integrated device. The test strip chemistry module (CHM) is an automated urine analyzer intended for the in vitro… |
At a glance
- 1–9 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: