Caredx Inc

FDA Filings

This page includes the latest FDA filings for Caredx Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

USANASDAQCDNADUNS 102819484

Caredx Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3005225997
FEI Number3005225997
NameCareDx, Inc.
Owner & OperatorCareDx, Inc.
Contact Address3260 BAYSHORE BOULEVARD --
Brisbane CA 94005 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3260 Bayshore Blvd
BRISBANE, CA 94005 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
CAREDX, INC.
 CareDx RMT-000112023-08-01
CAREDX, INC.
 UroMap Specimen Collection Kit UM-000012023-02-20
CAREDX, INC.
 KidneyCare Specimen Collection Kit AS-000052022-11-08
CAREDX, INC.
 KidneyCare Specimen Collection Kit AS-000042022-11-08
CAREDX, INC.
 HeartCare Specimen Collection Kit HTx-000092020-05-08
CAREDX, INC.
 Allomap Specimen Collection Kit 2020-05-08
CAREDX, INC.
 AlloSure Specimen Collection Kit AS-000022020-05-08
CareDx, Inc.
HeartCare Specimen Collection Kit2019-07-10
CareDx, Inc.
AlloSure Specimen collection kit2019-07-10
CareDx, Inc.
AlloMap Specimen Collection Kit2019-07-10
CareDx, Inc.
AlloMap Test2008-09-16
CareDx, Inc.
PROCESSING PACK2005-06-24
CareDx, Inc.
ALLOMAP SAMPLE COLLECTION2005-06-24

Similar & Related FDA Registered Companies

Related Finance Registrations
NCAGE Code53C84CAREDX, INC.
CAGE Code53C84CAREDX, INC.
S.A.M. Registration53C84 [102819484]CAREDX, INC.
SEC0001217234CareDx, Inc. of DELAWARE
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