UDI device identifier
Assure® Control - Control Solution Level 2 & Level 3 510006
UDI device identifier 00015482510060 · Arkray USA, Inc.
Key facts
| Primary DI | 00015482510060 |
|---|---|
| Brand name | Assure® Control - Control Solution Level 2 & Level 3 |
| Version or model | 510006 |
| Company | Arkray USA, Inc. |
| DUNS number | 008171162 |
| Product code | JJX |
| GMDN term | Glucose IVD, control |
| Device class | Class I |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Sep 26, 2025 |
| Version date | Aug 24, 2026 |
| Description | For use with the Assure Titanium Blood Glucose Monitoring System. Assure Control-Control Solution is used to check that the meter and test strips are working together properly and that the test is performing correctly. Carton contains 1 each of level 2 00015482510053 and level 3 00015482510077. |
At a glance
- None MAUDE reports citing this UDI
- No Linked premarket submission
- No EUDAMED counterpart found
- 1,000+ 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: