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Diagnostic Consulting Network, LLC.

United States US-MF-000044815 Last updated 25 Oct 2026

Devices
12
Registries
EUDAMEDGUDIDFDA
FDA recalls
0

Catalogue12

About

DCN Dx is a Carlsbad, California-based IVD contract development and manufacturing organization (CDMO) and clinical research organization (CRO). The CDMO develops and manufactures immunoassay-based diagnostics, including lateral flow assays, ELISA, and multiplex panels, from feasibility through commercial production. The CRO provides platform-agnostic clinical study design and management, biostatistics, data management, regulatory affairs, and prospective biospecimen collection services for diagnostic developers pursuing FDA 510(k), de novo, PMA, and EU IVDR clearance. ISO 13485 and ISO 9001 certified. Headquarters: 3193 Lionshead Ave, Suite 200, Carlsbad, CA 92010.

From the manufacturer's own website. Source

Information

Country
United States(from SRN)
Address
3193, Lionshead Ave., Carlsbad, United States
Website
www.dcndx.com
Phone
760.889.7186
PRRC contact
Nichole Navarro
EUDAMED SRN
US-MF-000044815
FDA FEI number
1000221318
DUNS number
788284177