FDA.reportPublic FDA data

Agendia Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30072978533007297853Agendia Inc1N2026-01-0122 Morgan Irvine CA US 92618
30178452623017845262Agendia NV1N2026-01-01Radarweg 60 Amsterdam Noord-Holland NL 1043 NT

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
00850024841321MammaPrint FFPE - MammaPrint® FFPE is a qualitative, non-automated in vitro diagnostic test, performed in a Agendia’s Diagnostic Service Laboratory, using the gene expression profile obtained from formalin-fixed paraffin embedded (FFPE) breast cancer tissue samples to assess a patient’s risk for distant metastasis within 5 years.MammaPrint provides prognostic information regarding patient’s risk of distant metastasis and prediction of the magnitude of systemic therapy benefit to guide treatment decisions in patients with breast cancer.The MammaPrint genes measure the characteristics of the multiple step development of breast cancer cells to survive, proliferate, disseminate and metastasize as covered within the hallmarks of cancer.The test is performed for female breast cancer patients, Stage I or Stage II disease who are lymph node negative or lymph node positive with up to 3 positive nodes and for patients with stage III disease. The MammaPrint® FFPE result is indicated for use by physicians and should be interpreted along with other clinico-pathological factors.1.888.321.2732customercare@agendia.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1042661669902089K201902MammaPrintNYI2020-11-05
2818121669902089K201902MammaPrintNYI2020-11-05
1042661740511973K141142MAMMAPRINT FFPENYI2015-01-23
2818121740511973K141142MAMMAPRINT FFPENYI2015-01-23
1042661888673195
2818121888673195
1042661971677538

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NYI42020-11-05

PMN#

GUDID#

MammaPrint FFPE - MammaPrint® FFPE is a qualitative, non-automated in vitro diagnostic test, performed in a Agendia’s Diagnostic Service Laboratory, using the gene expression profile obtained from formalin-fixed paraffin embedded (FFPE) breast cancer tissue samples to assess a patient’s risk for distant metastasis within 5 years.MammaPrint provides prognostic information regarding patient’s risk of distant metastasis and prediction of the magnitude of systemic therapy benefit to guide treatment decisions in patients with breast cancer.The MammaPrint genes measure the characteristics of the multiple step development of breast cancer cells to survive, proliferate, disseminate and metastasize as covered within the hallmarks of cancer.The test is performed for female breast cancer patients, Stage I or Stage II disease who are lymph node negative or lymph node positive with up to 3 positive nodes and for patients with stage III disease. The MammaPrint® FFPE result is indicated for use by physicians and should be interpreted along with other clinico-pathological factors.

Agendia, Inc.

2026-04-14