Strategic Manufacturing Partnership: Developing Custom Diagnostic Kits to Meet Your Precise Requirements

Reagent Manufacturing

ResearchDx strictly monitors the process from development to production of the reagents, and analyzes the performance indicators of the antibodies/antigens to ensure the difference between batches, stability and sensitivity of the reagents.

Kits Assembly and Packaging

ResearchDx offers multiple solutions for diagnostic packaging. Our healthcare expertise spans across the spectrum of diagnostics, giving you a competitive advantage. With a clear focus on quality, material knowledge, and end use, we’re an essential partner for your diagnostic packaging.

Custom LDT Kit Manufacture

Have a complex LDT that would benefit from being manufactured in kit form. RDx can manufacture, qualify and QC all reagents, controls and materials, and provide your clinical laboratory a ISO-13485 approved kit for your exclusive use.

Every project is tailored to your needs and has a dedicated project manager to guide and ensure your project stays on target with your goals and schedule. All projects are evaluated and designed by experienced PhD-level scientists with input from medical experts as needed. All development projects undergo analytical or clinical testing as required to meet quality and regulatory requirements, and/or the needs of the project.

ELISA Kit Production Services

We offer a comprehensive solutions for custom Enzyme-Linked Immunosorbent Assay (ELISA) kit development. We work closely with you to industrialize production conforming to ISO 13485, tailoring kits to your specific requirements. Whether for biomarker detection, disease diagnosis, or drug screening, the customized ELISA kits we produce provide robust and sensitive target analyte detection.

Process Optimization

We help you enhance cell culture processes, improve antibody purification strategies, and optimize buffer preparation to save time and increase productivity.

Registration and Certification

ResearchDx has unparalleled experience with US and international certification regulations and the requirements of the global import and export trade, to help your product certification and export.