FDA Record: Laboratory Corporation of America Holdings (Labcorp) (1000111938)

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000111938

FEI Number

1000111938

Entity Name

Laboratory Corporation of America Holdings (Labcorp)

City/State/Country

Burlington, NC, US

Establishment Address

1447 York Court, Burlington, NC 27215, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Laboratory Corporation of America Holdings (Owner Number: 10090790)

Owner / Operator Contact Address

358 S Main St., Burlington, NC 27215, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Labcorp Monkeypox PCR Test Home Collection Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QTQ	Reagents, Non-Variola Orthopoxvirus Nucleic Acid.	Unknown	Class N	N/A	2024-05-14

Official Correspondent

Maria Sur

US Agent Details

No US Agent registered (Local establishment).

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000111938. Last updated year: 2026. Please use registration number 1000111938 when referencing this establishment in official correspondence.

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