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- Country
- US
- Address
- 3260 Bayshore Blvd, BRISBANE, CA, 94005
- Website
- caredx.com
- —
- —
- [email protected]
- Phone
- 415-287-2427
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3005225997
- DUNS Number
- 102819484
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| HeartCare Specimen Collection Kit | HTx-00009 | FDA UDI | Class I | Active |
| CareDx | RMT-00011 | FDA UDI | Class II | Active |
| KidneyCare Specimen Collection Kit | AS-00004 | FDA UDI | Class I | Active |
| KidneyCare Specimen Collection Kit | AS-00005 | FDA UDI | Class I | Active |
| AlloSure Specimen Collection Kit | AS-00002 | FDA UDI | Class I | Active |
| Allomap Specimen Collection Kit | HTx-00007 | FDA UDI | Class I | Active |
| UroMap Specimen Collection Kit | UM-00001 | FDA UDI | Class I | Active |
| AlloMap Heart Molecular Expression Testing | K221640 | FDA 510(k) | Class II | Active |
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