UDI device identifier
Assure® Prism Control Solution 530006
UDI device identifier 00015482530068 · Arkray USA, Inc.
Key facts
| Primary DI | 00015482530068 |
|---|---|
| Brand name | Assure® Prism Control Solution |
| Version or model | 530006 |
| 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 | Jan 22, 2019 |
| Version date | Aug 24, 2026 |
| Description | Assure Prism Control Solution contains a known amount of glucose that reacts with the test strips and is used to check if the meter and test strips are working correctly as a system and you are testing correctly. Compare the control solution test result with the range printed on the test strip… |
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: