EUDAMED device
PSA-XS AccuLite CLIA Kit - 192 Wells
EUDAMED device 00816870022321 · Monobind Inc.
Key facts
| Primary DI | 00816870022321 |
|---|---|
| Trade name | PSA-XS AccuLite CLIA Kit - 192 Wells |
| Device name | Total Prostate Specific Antigen Extra Sensitive (tPSA-XS) AccuLite® CLIA Test System |
| Reference or catalog number | 8775-300B |
| Model | 8775-300 |
| Manufacturer | Monobind Inc. |
| Manufacturer SRN | US-MF-000021611 |
| Risk class | Class C |
| EMDN code | W0102030113 |
| EMDN description | TOTAL PROSTATIC SPECIFIC ANTIGEN |
| Legislation | ivdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Aug 5, 2025 |
At a glance
- Yes Matching FDA GUDID record
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About EUDAMED devices
EUDAMED is the European Union's database of medical devices registered under the MDR and IVDR, including UDI-DIs, risk classes and EMDN nomenclature codes.
Source: European Commission, European Database on Medical Devices (EUDAMED) · Source date: