Building Health, One Device at a Time
We offer a flexible approach to development and manufacturing.
Wherever you are in the process, we can assist in helping you achieve go-to-market success. Let’s team up and bring your next innovation to life!
Precision Turnkey Development & Manufacturing Services
We offer decades of experience in the development and manufacturing of IVD medical device systems and in vitro diagnostic devices.
We partner with leading healthcare companies and government agencies to bring your assays products to market. The low-to high-volume work we do serves the wellness, biodefense, veterinary, food safety, infectious disease, and women’s health care industries. Our US-based, privately-owned facility allows us the flexibility to pivot quickly in ramping up to address new projects or project transfers. We’re exclusively focused on LFI devices and medical diagnostics.
Our technologies can be found in more than 60+ diagnostic tests and has enabled us to produce more than 15+ million tests globally.
We produce a variety of FDA Class I, II, and III medical devices ranging from Research Use Only (RUO) to Biologicals License Applications (BLA) regulations, so you can be assured our quality systems are robust, but flexible to your needs.
Our quality systems are designed and operated in strict accordance with ISO 5, ISO 7, & ISO 8 Cleanrooms, ISO 13485:2016 Certified, FDA cGMP Registered and FDA CFR820 Compliant.
Maxim Biomedical, Inc. Secures $49.5 Million Manufacturing Award from U.S. HHS to Strengthen Pandemic Testing Efforts
MaximBio, a leading Maryland-based manufacturer specializing in lateral flow and diagnostic devices, is announcing the receipt of a $49.5 million award from the U.S. Department of Health and Human Services
MaximBio is proud to announce it has signed a new agreement with the National Institutes of Health (NIH) through the Rapid Acceleration of Diagnostics (RADx® ) initiative.
On October 26, 2023, the FDA granted a shelf-life extension for the MaximBio ClearDetect™ COVID-19 Antigen Home Test, which extended the shelf-life of all ClearDetect™ tests to 24 months.