UDI device identifier
SPOTCHEM™ II Creatinine 77116
UDI device identifier 00015482771164 · Arkray USA, Inc.
Key facts
| Primary DI | 00015482771164 |
|---|---|
| Brand name | SPOTCHEM™ II Creatinine |
| Version or model | 77116 |
| Company | Arkray USA, Inc. |
| DUNS number | 008171162 |
| Product code | CIJ |
| GMDN term | Magnesium (Mg2+) IVD, kit, spectrophotometry |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Sep 23, 2016 |
| Version date | Aug 24, 2026 |
| Description | Strip description for the invitro quantitative determination of creatinine concentration in human plasma from whole blood samples |
At a glance
- None MAUDE reports citing this UDI
- No 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: