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US
Last updated May 30, 2026
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 964789676
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SeptiCyte RAPID | SA3010U | FDA UDI | Class II | Active |
| SeptiCyte RAPID [US IVD] | SB3020U | FDA UDI | Class II | Active |
| SeptiCyte RAPID | SB3010U | FDA UDI | Class II | Active |
| SeptiCyte RAPID [US IVD] | SA3020U | FDA UDI | Class II | Active |
| SeptiCyte RAPID | K203748 | FDA 510(k) | Class II | Active |
| SeptiCyte RAPID | K232095 | FDA 510(k) | Class II | Active |
| SeptiCyte LAB | K163260 | FDA 510(k) | Class II | Active |
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