Creating Transformative Diagnostic Kits and Reagents
Custom diagnostic, analytical and OEM kits and reagents, made under an ISO 13485:2016 quality system in our FDA-registered facility in Irvine, California.
All manufacturing is performed under the ResearchDx ISO 13485:2016 certified quality management system in our FDA-registered facility in Irvine, California.
What We Manufacture
Assays, reagents, controls and final kits for research, nonclinical and clinical use — built to your specifications and released with full QC documentation.
Reagent Manufacturing
Controlled production with antibody and antigen performance assessment to manage lot-to-lot variation, stability and sensitivity.
Kit Assembly & Packaging
Packaging and kitting designed around your materials and end use, including sample collection and shipping kits.
Custom LDT Kit Manufacture
Convert your laboratory-developed test into a kit, with manufacturing, qualification and QC of reagents, controls and materials.
OEM Kits
Custom OEM diagnostic and analytical kits and components for biomarker detection, diagnosis and drug screening.
Controls & Pilot Lots
Custom assay controls and materials, plus pilot and small-batch lots to de-risk scale-up before production.
Regulatory & Supply
Support with US and international registration and import/export requirements, and ongoing supply-chain management.
Our Process
1. Design Transfer
We work with you to specify your assay and transfer the design into manufacturing.
2. Pilot Lots
We build and qualify pilot lots before committing to production.
3. QC Release
Every lot is released with QC testing and a Certificate of Analysis.
4. Ongoing Supply
We provide continuing supply and process improvement as you scale.
One partner. Three strengths.
Develop, test and manufacture your diagnostic without changing vendors
ResearchDx, PacificDx and CustomDx work side by side in one Irvine facility, so your assay moves from discovery to clinical testing to finished kits without a hand-off.
Let's Build Your Kit
ResearchDx, Inc. · 5 Mason, Irvine, CA 92618, USA
Phone: 949-812-6902 · Toll free: 866-225-9195