Data / Medical devices / United States / CareDx, Inc.
CareDx, Inc.: FDA-registered device maker in Brisbane, CA, United States, 1 510(k) clearance
CareDx, Inc. is registered with the FDA (registration 3005225997) in Brisbane, CA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 13, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005225997
- Address
- 3260 Bayshore Blvd, Brisbane, CA, United States, 94005
- Owner or operator
- CareDx, Inc. (9074467)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- June 24, 2005
- Registered through
- 2026
- Brand names listed
- ALLOMAP SAMPLE COLLECTION, AlloMap Heart, AlloMap Specimen Collection Kit, AlloSure Specimen collection kit, HeartCare Specimen Collection Kit, KidneyCare Mobile Specimen Collection Kit, KidneyCare Specimen Collection kit, PROCESSING PACK
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Specimen Collection Kit (Excludes Hiv Testing) | OFZ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Cardiac Allograft Gene Expression Profiling Test System | OJQ | 2 | Manufacturer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 13, 2023 | K221640 | AlloMap Heart Molecular Expression Testing | OJQ | Substantially Equivalent | Caredx, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of General Purpose Reagent
- All makers of Blood Specimen Collection Kit (Excludes Hiv Testing)
Updated September 13, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.