UDI device identifier
AUTION™ Sticks 9EB - Test Strips 110734
UDI device identifier 00015482117344 · Arkray USA, Inc.
Key facts
| Primary DI | 00015482117344 |
|---|---|
| Brand name | AUTION™ Sticks 9EB - Test Strips |
| Version or model | 110734 |
| Company | Arkray USA, Inc. |
| DUNS number | 008171162 |
| Product code | KQO |
| GMDN term | Urine analyser IVD, laboratory |
| Premarket submission | K193514 |
| Device class | Class I |
| Single use | Yes |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Dec 2, 2024 |
| Version date | Aug 24, 2026 |
| Description | AUTION Sticks 9EB test strips are test strips for the in vitro qualitative or semi-quantitative measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, turbidity, and color. The test results of these parameters can be used in the… |
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: