SCALABLE, COMPLIANT, CUSTOM: YOUR OEM MANUFACTURING PARTNER IN DIAGNOSTICS
- info7637144
- Aug 5
- 2 min read
When quality, flexibility, and scalability matter, MRN Diagnostics delivers with precision.
Our OEM manufacturing services are designed for diagnostic developers seeking a trusted partner for high-quality, compliant production of biological materials, R&D panels, and control kits. From assay development to commercial launch, we provide the infrastructure, expertise, and flexibility needed to scale confidently.
FLEXIBLE, END-TO-END OEM MANUFACTURING
Our manufacturing services include:
Liquid and swab-based quality controls and calibrators for serology, antigen, and molecular testing. Covers testing formats from CLIA-Waived point-of-care to large-scale screening platforms.
Custom in-process quality control panel design and development.
GMP-compliant plasma and serum processing (defibrination, diafiltration, lipid stripping, sterile filtration, viral inactivation, and stabilization).
Large-scale bioprocessing for volumes up to 500L.
Our manufacturing processes are cGMP and ISO 13485:2016 compliant, which provides the regulatory support and documentation needed for audits, manufacturing operations, and submissions for regulatory approval.
CUSTOM SOLUTIONS FOR MODERN DIAGNOSTICS
At MRN Diagnostics, we specialize in the custom development and manufacturing of control kits and validation panels tailored to your unique assay needs. Whether you require small-batch R&D support or high-volume production, we ensure every product meets rigorous performance and regulatory standards.
CONFIDENCE FROM FEASIBILITY TO COMMERCIALIZATION
Whether preparing for FDA or CLIA submission, launching a new assay, or expanding post-market production, MRN Diagnostics is your go-to partner for proven performance and regulatory peace of mind.
Our scientific and manufacturing experts are ready to collaborate on your next project. If you are looking to streamline your workflow, ensure lot-to-lot consistency, and bring superior diagnostics to market, we are here to help.
If you have any questions, would like to schedule a follow-up discussion, or are ready to begin a custom project, we encourage you to get in touch with our team. We are happy to assist with quoting, project scoping, or exploring the right solutions for your next phase of work.
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