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Laboratory Corporation of America Holdings

United States·US-MF-000017722

Last updated September 18, 2026

About

Labcorp helps patients, providers, organizations, and biopharma companies to guide vital healthcare decisions each and every day.

From the manufacturer's own website. Source

What Laboratory Corporation of America Holdings makes

The company develops and provides in vitro diagnostic (IVD) assays and genetic tests, including immune profiling assays, genomic profiling tests, lipid panel assays, and APOL1 genotyping tests. These products are designed for clinical use in assessing genetic predispositions, immune responses, and biomarkers related to cardiovascular and genetic conditions. Additional offerings include neutralizing antibody assays for adeno-associated virus (AAV) vectors, used in gene therapy research and development. The company also provides a comprehensive oncology-focused LDT assay for detecting genetic mutations in cancer patients.

The portfolio includes devices classified under Class I and IVD General categories, with regulatory listings in the EU’s eudamed database and the FDA’s 510(k) clearance registry. These devices are intended for use in laboratory settings and are governed by applicable IVD regulations in the United States and European Union. The company operates primarily from its headquarters in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
United States
Address
531 S. Spring Street, Burlington, United States
Phone
—
PRRC Contact
Irene Bacalocostantis
EUDAMED SRN
US-MF-000017722
FDA FEI Number
—
DUNS Number
—

Catalogue (9)

DeviceModel / ReferenceRegistriesClassStatus
OI-immune profiling assay OI-IPA
EUDAMED
IVD GeneralActive
ApoE Genotype Test 820133-165
EUDAMED
IVD GeneralActive
Extended Lipid Panel Assay K181373
FDA 510(k)
Class IActive
OI-genomic profiling assay OI-GPA
EUDAMED
IVD GeneralActive
APOL1 Genotyping Test 80-061-00
EUDAMED
IVD GeneralActive
Anti-AAv9 nAb Anti-AAV9 nAb
EUDAMED
IVD GeneralActive
nAbCyte Anti-AAVRh74var HB-FE Assay Anti-Spark 100 nAb Assay
EUDAMED
IVD GeneralActive
TruSight Oncology 500 LDT Assay (TS0500) TSO500LDT
EUDAMED
IVD GeneralActive
Anti-AAV6 nAb Assay Anti-AAV6 nAb Assay
EUDAMED
IVD GeneralActive

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