Maxim Biomedical, Inc.
Maxim Biomedical (MaximBio) is a leading healthcare diagnostic company founded in 2005, dedicated to developing and manufacturing affordable, accessible diagnostic solutions to improve patient outcomes worldwide. The company specializes in lateral flow and diagnostic devices, with a focus on in vitro diagnostic (IVD) medical device systems. They serve industries including wellness, biodefense, veterinary, food safety, infectious disease, and women’s health care, with technologies found in over 60 diagnostic tests and more than 15 million tests produced globally. MaximBio emphasizes quality, innovation, and collaboration, partnering with healthcare companies and government agencies to bring new diagnostic products to market.
Industries
Nr. of Employees
small (1-50)
Maxim Biomedical, Inc.
1500 East Gude Drive, Suite A, Rockville, MD, 20850
Products
COVID-19 antigen home test (EUA-authorized antigen test)
An over-the-counter antigen test for SARS-CoV-2 intended for at-home use under Emergency Use Authorization.
HIV-1 LAg-Avidity DBS ELISA kit (research use)
A dried blood spot (DBS) limiting antigen avidity ELISA intended for surveillance and incidence estimation (research use only).
COVID-19 antigen home test (EUA-authorized antigen test)
An over-the-counter antigen test for SARS-CoV-2 intended for at-home use under Emergency Use Authorization.
HIV-1 LAg-Avidity DBS ELISA kit (research use)
A dried blood spot (DBS) limiting antigen avidity ELISA intended for surveillance and incidence estimation (research use only).
Services
End-to-end development from concept and prototyping through scale-up, verification/validation, and commercial production for IVD devices.
Formulation, preparation, and semi-automated/automated filling of buffer and reagent batches up to 1,000 L with cleanroom filling capability.
Automated assembly of devices and kits, kitting, packaging, labeling, and logistics support for commercial distribution.
Quality system implementation and regulatory support aligned with ISO 13485, FDA cGMP registration, CFR820 compliance, and device submission processes.
Conducting and documenting stability studies to support expiration dating and regulatory submissions for shelf-life extensions.
End-to-end development from concept and prototyping through scale-up, verification/validation, and commercial production for IVD devices.
Formulation, preparation, and semi-automated/automated filling of buffer and reagent batches up to 1,000 L with cleanroom filling capability.
Automated assembly of devices and kits, kitting, packaging, labeling, and logistics support for commercial distribution.
Quality system implementation and regulatory support aligned with ISO 13485, FDA cGMP registration, CFR820 compliance, and device submission processes.
Conducting and documenting stability studies to support expiration dating and regulatory submissions for shelf-life extensions.
Expertise Areas
- Lateral flow assay development and manufacturing
- Point-of-care and over-the-counter diagnostic development
- IVD assay development (LFA and ELISA)
- Assay scale-up and GMP manufacturing
Key Technologies
- Lateral flow immunoassays (LFA)
- Enzyme-linked immunosorbent assay (ELISA)
- Multiplex immunoassays
- Visual and fluorescent labeling
News & Updates
MaximBio received a second NIH RADx Tech High Performance Award for the development of at-home FiarFly™ Reader and COVID-19 & Flu A/B Rapid Test.
MaximBio announced a $49.5 million award from the U.S. Department of Health and Human Services to strengthen pandemic testing efforts.
On October 26, 2023, the FDA extended the shelf-life of all ClearDetect™ COVID-19 tests to 24 months.
MaximBio received Emergency Use Authorization for their COVID-19 antigen home test.
MaximBio announced plans to produce millions of point-of-care COVID-19 tests delivering results in 15 minutes.
MaximBio received a second NIH RADx Tech High Performance Award for the development of at-home FiarFly™ Reader and COVID-19 & Flu A/B Rapid Test.
MaximBio announced a $49.5 million award from the U.S. Department of Health and Human Services to strengthen pandemic testing efforts.
On October 26, 2023, the FDA extended the shelf-life of all ClearDetect™ COVID-19 tests to 24 months.
MaximBio received Emergency Use Authorization for their COVID-19 antigen home test.
MaximBio announced plans to produce millions of point-of-care COVID-19 tests delivering results in 15 minutes.