CareDx, Inc.

FDA Device Registration & Listing · BRISBANE, CA, US · Registration 3005225997

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3005225997
FEI Number
3005225997
Entity Name
CareDx, Inc.
City/State/Country
BRISBANE, CA, US
Establishment Address
3260 Bayshore Blvd, BRISBANE, CA 94005, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
CareDx, Inc. (Owner Number: 9074467)
Owner / Operator Contact Address
3260 BAYSHORE BOULEVARD, --, Brisbane, CA 94005, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

AlloSure Specimen collection kit HeartCare Specimen Collection Kit AlloMap Specimen Collection Kit KidneyCare Mobile Specimen Collection Kit KidneyCare Specimen Collection kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OFZ Blood Specimen Collection Kit (Excludes Hiv Testing) Anesthesiology Class 1 868.1100 2019-07-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CareDx, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005225997. Last updated year: 2026. Please use registration number 3005225997 when referencing this establishment in official correspondence.
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