Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002522915

FEI Number

3002522915

Entity Name

CAREDX AB

City/State/Country

STOCKHOLM, SE

Establishment Address

Franzengatan 5, STOCKHOLM SE-112 51, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CareDx AB (Owner Number: 10029422)

Owner / Operator Contact Address

Franzengatan 5, Stockholm, SE-AB 11251, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

BK080022

PMA Number

N/A

All Registered Proprietary Names

Olerup SSP® HLA typing kits

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MZI	Test, Qualitative, For Hla, Non-Diagnostic	Unknown	Class U	N/A	2009-05-13

Official Correspondent

Maria Ilar

US Agent Details

Wilk von Gustedt Business: CareDx Inc. Email: wgustedt@caredx.com Phone: (415) 2872312

Related Public Records

Same Entity

CareDx AB

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002522915. Last updated year: 2026. Please use registration number 3002522915 when referencing this establishment in official correspondence.