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Sign in to claim this brandGenMark Diagnostics
United States·US-MF-000010772
Last updated June 8, 2026
Information
- Country
- United States
- Address
- 5964, La Place Ct, CARLSBAD, United States
- Website
- roche.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Jeff Boone
- EUDAMED SRN
- US-MF-000010772
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (32)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ePlex | BCID-GP Cartridge Pouch | FDA UDI | Class II | Active |
| eSensor® XT-8 | Warfarin Sensitivity Test (WST) | FDA UDI | N/A | Unknown |
| ePlex | BCID-GN 12 Kit Box | FDA UDI | Class II | Active |
| ePlex | BCID_FP Cartridge Pouch | FDA UDI | Class II | Active |
| ePlex System | ePlex Respiratory Panel (RP) | FDA UDI | Class II | Active |
| ePlex | BCID-GP 12 Kit Box | FDA UDI | Class II | Active |
| ePlex | BCID-GN Cartridge Pouch | FDA UDI | Class II | Active |
| ePlex | BCID-FP 12 Kit Box | FDA UDI | Class II | Active |
| eSensor® XT-8 | eSensor® Respiratory Viral Panel (RVP) | FDA UDI | N/A | Unknown |
| eSensor® XT-8 | eSensor® Cystic Fibrosis (CF) | FDA UDI | N/A | Unknown |
| eSensor® XT-8 | eSensor® Thrombophilia Risk Test (TRT) | FDA UDI | N/A | Unknown |
| ePlex System | ePlex Respiratory Panel (RP) | FDA UDI | Class II | Active |
| eSensor® XT-8 | eSensor® Cystic Fibrosis (CF) | FDA UDI | N/A | Unknown |
| eSensor® XT-8 | eSensor® Cystic Fibrosis (CF) | FDA UDI | N/A | Unknown |
| eSensor® XT-8 | Warfarin Sensitivity Test (WST) | FDA UDI | N/A | Unknown |
| ePlex System | ePlex Respiratory Panel (RP) | FDA UDI | Class II | Active |
| eSensor® XT-8 | eSensor® Thrombophilia Risk Test (TRT) | FDA UDI | N/A | Unknown |
| eSensor® XT-8 | eSensor® Respiratory Viral Panel (RVP) | FDA UDI | N/A | Unknown |
| eSensor® XT-8 | eSensor® Cystic Fibrosis (CF) | FDA UDI | N/A | Unknown |
| eSensor® XT-8 | Warfarin Sensitivity Test (WST) | FDA UDI | N/A | Unknown |
| eSensor® XT-8 | eSensor® Thrombophilia Risk Test Reagent Test (TRT) | FDA UDI | N/A | Unknown |
| eSensor® XT-8 | eSensor® Respiratory Viral Panel (RVP) | FDA UDI | N/A | Unknown |
| eSensor® XT-8 | eSensor® Thrombophilia Risk Test (TRT) | FDA UDI | N/A | Unknown |
| eSensor® XT-8 | eSensor® Respiratory Viral Panel (RVP) | FDA UDI | N/A | Unknown |
| eSensor® XT-8 | eSensor® Respiratory Viral Panel (RVP) | FDA UDI | N/A | Unknown |
| eSensor® XT-8 | eSensor® Thrombophilia Risk Test (TRT) | FDA UDI | N/A | Unknown |
| eSensor® XT-8 | Warfarin Sensitivity Test (WST) | FDA UDI | N/A | Unknown |
| eSensor® XT-8 | eSensor® Cystic Fibrosis (CF) | FDA UDI | N/A | Unknown |
| eSensor® XT-8 | Warfarin Sensitivity Test (WST) | FDA UDI | N/A | Unknown |
| cobas® eplex system | 10107545001 | EUDAMED | Class A | Active |
| Esensor Warfarin Sensitivity Saliva Test | K110786 | FDA 510(k) | Class II | Active |
| cobas® eplex respiratory pathogen panel 3 (RP3) | 10246944001 | EUDAMED | Class B | Active |
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