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Sign in to claim this brandLaboratory 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
- Website
- www.labcorp.com
- linkedin.com/company/labcorp
- facebook.com/Labcorp
- [email protected]
- Phone
- —
- PRRC Contact
- Irene Bacalocostantis
- EUDAMED SRN
- US-MF-000017722
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| OI-immune profiling assay | OI-IPA | EUDAMED | IVD General | Active |
| ApoE Genotype Test | 820133-165 | EUDAMED | IVD General | Active |
| Extended Lipid Panel Assay | K181373 | FDA 510(k) | Class I | Active |
| OI-genomic profiling assay | OI-GPA | EUDAMED | IVD General | Active |
| APOL1 Genotyping Test | 80-061-00 | EUDAMED | IVD General | Active |
| Anti-AAv9 nAb | Anti-AAV9 nAb | EUDAMED | IVD General | Active |
| nAbCyte Anti-AAVRh74var HB-FE Assay | Anti-Spark 100 nAb Assay | EUDAMED | IVD General | Active |
| TruSight Oncology 500 LDT Assay (TS0500) | TSO500LDT | EUDAMED | IVD General | Active |
| Anti-AAV6 nAb Assay | Anti-AAV6 nAb Assay | EUDAMED | IVD General | Active |
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