UDI device identifier
AUTION EYE™ Sheath Solution - 10L Bottle 108155
UDI device identifier 00015482181550 · Arkray USA, Inc.
Key facts
| Primary DI | 00015482181550 |
|---|---|
| Brand name | AUTION EYE™ Sheath Solution - 10L Bottle |
| Version or model | 108155 |
| Company | Arkray USA, Inc. |
| DUNS number | 008171162 |
| Product code | KQO |
| GMDN term | Urine analyser IVD, laboratory |
| Premarket submission | K232416 |
| Device class | Class I |
| Single use | Yes |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Dec 2, 2024 |
| Version date | Aug 24, 2026 |
| Description | AUTION EYE Sheath Solution is intended for in vitro diagnostic use with the AUTION EYE AI-4510 analyzer to identify formed particles in urine samples through flow cell cytometry. |
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: