AFFIMEDIX, INC.

FDA Device Registration & Listing · Hayward, CA, US · Registration 3014862385

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
3014862385
FEI Number
3014862385
Entity Name
AFFIMEDIX, INC.
City/State/Country
Hayward, CA, US
Establishment Address
3556 Investment Blvd., Hayward, CA 94545, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
Owner / Operator
Affimedix, Inc. (Owner Number: 10088365)
Owner / Operator Contact Address
3556 Investment Blvd., Hayward, CA 94545, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Rapi-D™ Quantitative Vitamin D Test TestNOW® - Cortisol Quantitative Test TestNOW® - Ferritin Quantitative Test TestNOW® - Testosterone Quantitative Test

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MRG System, Test, Vitamin D Clinical Chemistry Class 2 862.1825 2023-07-08

Official Correspondent

Arun Jaiswal

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K200509 Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Vitamin D Total (VitD) 2020-05-29

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014862385. Last updated year: 2026. Please use registration number 3014862385 when referencing this establishment in official correspondence.
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