EUDAMED device
AFP, CEA & PSA AccuLite VAST CLIA Kit - 960 wells
EUDAMED device 00816870022123 · Monobind Inc.
Key facts
| Primary DI | 00816870022123 |
|---|---|
| Trade name | AFP, CEA & PSA AccuLite VAST CLIA Kit - 960 wells |
| Device name | Alpha-Fetoprotein,Carcinoembryonic Antigen and Total Prostate Specific Antigen (AFP/CEA/tPSA) VAST® AccuLite® CLIA Test System |
| Reference or catalog number | 8475-300E |
| Model | 8475-300 |
| Manufacturer | Monobind Inc. |
| Manufacturer SRN | US-MF-000021611 |
| Risk class | Class C |
| EMDN code | W0102030112,W0102030122,W0102039001 |
| EMDN description | ALPHAFETOPROTEIN|CARCINOEMBRYONIC ANTIGEN|EARLY PROSTATE CANCER ANTIGEN - 2 |
| Legislation | ivdr |
| Implantable | No |
| Sterile | No |
| Single use | No |
| Status date | Aug 6, 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: