Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011854503

FEI Number

3011854503

Entity Name

BIODESIX, INC.

City/State/Country

Louisville, CO, US

Establishment Address

919 W Dillon Rd, Suite 100, Louisville, CO 80027, US

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Biodesix, Inc. (Owner Number: 10084036)

Owner / Operator Contact Address

919 W Dillon Rd, Suite 100, Louisville, CO 80027, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IQLung Specimen Collection Kit Capillary Blood Specimen Collection Supplemental Pack Nodify Lung Specimen Collection Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PQD	Blood Specimen Collection Convenience Kit (Excludes Hiv)	Clinical Chemistry	Class 2	862.1675	2022-01-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Biodesix, 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 3011854503. Last updated year: 2026. Please use registration number 3011854503 when referencing this establishment in official correspondence.