Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1930987

FEI Number

1930987

Entity Name

LABONE, INC.

City/State/Country

LENEXA, KS, US

Establishment Address

10101 Renner Blvd, LENEXA, KS 66219, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

LABONE, LLC., d/b/a Quest Diagnostics (Owner Number: 9004417)

Owner / Operator Contact Address

10101 RENNER BLVD., --, Lenexa, KS 66219, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Convenience Kit for Collecting and Transporting Upper Respiratory Specimens HairCheck-DT (THC) Delayed Semen Analysis Media US Urine Examiner Kit US Paramed Collection Oral Fluid Kit US Blood And Urine Kit QCard WHS Quest Diagnostics Collection Kit for COVID-19 (Individual & Activate) Quest Diagnostics Collection Kit for COVID-19 (Bulk) Quest Diagnostics Collection Kit for COVID-19 (Bulk & Activate) Quest Diagnostics Collection Kit for COVID-19 (Individual)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	Class 1	866.2300	2020-08-19
PVJ	Test, Cannabinoid, Employment And Insurance Testing, Exempt	Clinical Toxicology	Class 2	862.3870	2018-03-05
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2019-09-03
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2001-11-06
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2019-04-17
QLW	Covid-19 Test Home Collection Kit Devices	Unknown	Class N	N/A	2021-12-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LABONE, LLC., d/b/a Quest Diagnostics

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
K880142	Hardy Media	TSA W/LEC. & TWEEN. 80	1988-03-30

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1930987. Last updated year: 2026. Please use registration number 1930987 when referencing this establishment in official correspondence.