dcndx.com valid
DCN Dx
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 dia
- Authority
- 50 reach 0 · trust 10 · quality 25 · freshness 15
- Tier
- listed
- llms.txt
- https://dcndx.com/llms.txt
- llms-full.txt
- https://dcndx.com/llms-full.txt
- Sections
- 11
- Links
- 162
- Size
- 35795 bytes
- Registered
- 2004-03-15
- Country
- United States Hosting inference
- Hosting country
- United States Hosting inference
- Country evidence
- No published address evidence collected yet
- Categories
- Industry and manufacturing
- For agents
- Documentation: developer or product docs worth reading, nothing to call
- First seen
- 2026-10-24T18:58:28.429Z
- Last checked
- 2026-10-24T18:58:32.423Z
- Badge
Their llms.txt
The beginning of the file, from our validated copy saved 2026-10-24T18:58:28.659Z. Cached copy · Source on dcndx.com
# DCN Dx
> 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.
## Services
- [Services Overview](https://dcndx.com/services/): Integrated CDMO and CRO services for IVD developers.
- [CDMO](https://dcndx.com/services/cdmo/): Contract development and manufacturing of immunoassay-based diagnostics.
- [Contract Assay Development](https://dcndx.com/services/cdmo/contract-assay-development/): Custom lateral flow, ELISA, and multiplex assay development.
- [Contract Manufacturing](https://dcndx.com/services/cdmo/contract-manufacturing/): ISO 13485–compliant IVD manufacturing.
- [Aseptic Filling](https://dcndx.com/services/cdmo/aseptic-filling/): Aseptic filling services for diagnostic reagents.
- [Consumable & Cassette Design](https://dcndx.com/services/cdmo/consumable-cassette-design/): Custom consumable and cassette engineering.
- [Custom Readers](https://dcndx.com/services/cdmo/custom-readers/): Custom diagnostic reader design and integration.
- [Clinical Validation & Regulatory](https://dcndx.com/services/cdmo/clinical-validation-regulatory/): Clinical validation and regulatory support for CDMO programs.
- [CDMO Consulting](https://dcndx.com/services/cdmo/consulting/): Strategic consulting for IVD development programs.
- [CRO (Clinical Research)](https://dcndx.com/services/cro-clinical-research/): Platform-agnostic IVD clinical research services.
- [Trial Management](https://dcndx.com/services/cro-clinical-research/trial-management/): End-to-end IVD clinical trial management.
- [Site Development](https://dcndx.com/services/cro-clinical-research/site-development/): Clinical trial site development and activation.
- [Data Management](https://dcndx.com/services/cro-clinical-research/data-management/): Clinical data management for IVD studies.
- [Biostatistics](https://dcndx.com/services/cro-clinical-research/biostatistics/): Biostatistical design and analysis for diagnostic studies.
- [Regulatory](https://dcndx.com/services/cro-clinical-research/regulatory/): FDA, EU IVDR, and global regulatory strategy.
- [CRO Consulting](https://dcndx.com/services/cro-clinical-research/consulting/): Strategic CRO consulting for IVD developers.
- [Biospecimen Service](https://dcndx.com/services/biospecimen/): Prospective biospecimen collection for IVD clinical validation.
- [LFA Development Services](https://dcndx.com/lfa-development-services/): Lateral f
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