Manufacturing
Lumos has a world-class ISO 13485 certified Original Equipment Manufacturer (OEM) facility located in Carlsbad, California. Our Manufacturing and R&D teams are co-located to reduce the time and risk of transfer into production, and for ongoing support.
Contact us to learn more about Lumos Manufacturing
Contact usDiagnostic Test Manufacturing & Kitting
Lumos is an experienced full-scale manufacturer of diagnostic reagents, cartridges and test kits. Our team includes highly skilled manufacturing scientists and technicians with medical device experience, as well as a specialized quality team.
The Lumos manufacturing facilities include state-of-the-art automation systems, and temperature and humidity controlled rooms to meet the environmental needs for different production steps.
Manufacturing Transfer and Process Validation
The co-location of development and manufacturing teams at Lumos greatly assists in design transfer for products developed in-house as well as externally developed devices. Our team will generate the required raw materials, manufacturing and QC procedure documentation prior to initiating the manufacture of process validation lots at volumes tailored to our client needs.
Scalable Device Manufacturing
Lumos manufacturing provides flexibility, adapting to changing production volume needs. Our batch mode operations is useful to meet initial volumes at product launch, prior to scale up onto our state-of-the-art automation systems. Our team is experienced in managing all aspects of the supply chain delivering finished goods to meet specific regulatory needs.
Reader Manufacturing
Lumos' mature reader platforms provide a fast-tracked path to manufactured devices by leveraging our existing supply chain, production lines and manufacturing processes.
Standard reader customizations to incorporate client branding and assay specific data files is easily implemented in production, assisted through co-located engineering teams.
Lumos standard and customized readers are manufactured to ISO 13485.
Frequently asked questions
What types of point-of-care products can Lumos Diagnostics manufacture under contract?
Lumos Diagnostics is a full-scale contract manufacturer of point-of-care (POC) diagnostic products, including lateral flow immunoassays, reagents, test kits and digital readers from our ISO 13485 certified manufacturing facilities. From clinical trial batch production to high-volume commercial manufacturing, Lumos Diagnostics provides end-to-end supply chain management under certified cGMP and ISO 13485 medical device quality systems.
How does Lumos Diagnostics reduce risk when transferring a product from development into manufacturing?
Lumos Diagnostics specializes in Design for Manufacturability and uses a structured technology transfer process to transition products from prototype stage to pilot manufacturing and global commercial scale. Our manufacturing and R&D teams are co-located within the one facility, ensuring products are designed with manufacturing in mind and reducing time and risk when transferring a product into production.
Can Lumos Diagnostics manufacturing scale with our production volume needs?
Lumos Diagnostics manufacturing is built to adapt as production volume needs change over time. Batch mode operations support the lower initial volumes needed for clinical trials and product launch, with a path to scale up onto Lumos's automation systems as demand grows. The team also manages the supply chain end to end, delivering finished goods that meet specific regulatory requirements.
Why partner with Lumos Diagnostics for full-service manufacturing?
Partnering with Lumos Diagnostics for end-to-end contract manufacturing provides a single-source solution that integrates assay and test kit production with Lumos Reader Platform manufacturing. Managing chemistry, optical hardware, and digital software under one ISO 13485 quality system shortens commercialization timelines by 6 to 12 months and eliminates multi-vendor supply chain risk.
Can Lumos support regulatory filings (FDA 510(k), CLIA waivers, IVDR) for manufactured products?
Lumos Diagnostics Contract Manufacturing, Assay Development, and Reader Development teams operate under an ISO 13485 medical device quality management system. Lumos Diagnostics also maintains an in-house Quality and Regulatory Affairs team with experience across global IVD/medical device test development, regulatory strategy, submissions, and quality management systems. The team generates the comprehensive Medical Device File (MDF) and analytical performance data needed for global regulatory submissions, including FDA 510(k) clearance, CLIA waiver, and IVDR compliance. Lumos also brings a proven track record of its own: our FebriDx test has received FDA 510(k) clearance and a subsequent CLIA waiver, alongside clearances in 17 countries.