FDA.reportPublic FDA data

CAREDX AB

Matched from indexed company URL: Caredx, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30025229153002522915CAREDX AB1N2026-01-01Franzengatan 5 STOCKHOLM SE SE-112 51
30052259973005225997CareDx, Inc.1N2026-01-013260 Bayshore Blvd BRISBANE CA US 94005
30076701683007670168CareDx Lab Solutions Inc1Y2026-01-01901 S Bolmar St Suite R West Chester PA US 19382

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860193001754CareDx - Needle, Vacutainer® Safety-Lok™ Blood Collection Set4152872427rramirez@caredx.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
241961960653247K221640AlloMap Heart Molecular Expression TestingOJQ2023-09-13
241961667782711DEN080007ALLOMAP MOLECULAR EXPRESSION TESTINGOJQ2008-08-26
1038381297146505BK090042
1038381672594255BK080022
1038381768631062BK070011
241961758787835
241961923081710

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OJQ22023-09-13

PMN#

GUDID#

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