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.

Diagnostic 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.

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