Agendia Inc

FDA Device Registration & Listing · Irvine, CA, US · Registration 3007297853

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
3007297853
FEI Number
3007297853
Entity Name
Agendia Inc
City/State/Country
Irvine, CA, US
Establishment Address
22 Morgan, Irvine, CA 92618, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
AGENDIA Inc. (Owner Number: 9101719)
Owner / Operator Contact Address
Agendia Inc., 22 Morgan, Irvine, CA 92618, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K141142
PMA Number
N/A

All Registered Proprietary Names

MammaPrint® BluePrint® Breast Cancer Recurrence and Molecular Subtyping Kit MammaPrint® FFPE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NYI Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer Immunology Class 2 866.6040 2025-12-29
NYI Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer Immunology Class 2 866.6040 2018-11-27

Official Correspondent

Melissa Chavis

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AGENDIA Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3017845262 Agendia NV Amsterdam Noord-Holland, NL

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007297853. Last updated year: 2026. Please use registration number 3007297853 when referencing this establishment in official correspondence.
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