Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016504919

FEI Number

3016504919

Entity Name

IMMUNEXPRESS, INC

City/State/Country

Seattle, WA, US

Establishment Address

425 Pontius Avenue North, Suite 470, Seattle, WA 98109, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Immunexpress, Inc (Owner Number: 10083917)

Owner / Operator Contact Address

425 Pontius Avenue North, Suite 470, Seattle, WA 98109, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232095

PMA Number

N/A

All Registered Proprietary Names

SeptiCyte RAPID

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PRE	Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers	Microbiology	Class 2	866.3215	2023-12-28

Official Correspondent

LaKesha Hunt

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Immunexpress, Inc

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 3016504919. Last updated year: 2026. Please use registration number 3016504919 when referencing this establishment in official correspondence.