UDI device identifier
GLUCOCARD® Expression™ Level 1 Control Solution 570005
UDI device identifier 00015482570002 · Arkray USA, Inc.
Key facts
| Primary DI | 00015482570002 |
|---|---|
| Brand name | GLUCOCARD® Expression™ Level 1 Control Solution |
| Version or model | 570005 |
| Company | Arkray USA, Inc. |
| DUNS number | 008171162 |
| Product code | NBW |
| GMDN term | Glucose IVD, control |
| Premarket submission | K102037 |
| Device class | Class II |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Sep 25, 2018 |
| Version date | Aug 24, 2026 |
| Description | GLUCOCARD Expression Level 1 Control Solution. The purpose of the control solution test is to validate the performance of the Blood Glucose Monitoring System using a testing solution with a known range of glucose. (Primary UPC# 015482570002 is used as the assigned UDI for the Class I device.) |
At a glance
- None MAUDE reports citing this UDI
- Yes 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: