Maxim Biomedical, Inc. (Maxim), located in the Rockville, Maryland, was founded in May 2005. Our mission at Maxim is to develop and market in vitro diagnostic (IVD) and Point-of-care (POC) testing solutions that make positive contributions to public health and healthcare worldwide. Customers can opt-in for our customized CRO/CMO services or purchase from our existing line of FDA or CDC approved products. Our urine and oral-based HIV ELISA and Western Blot tests are designed to be safe, cost-effective, and painless, while our blood-based tests offer proven solutions in a traditional format. We believe that by offering both non-blood and traditional blood-based testing solutions for HIV infection and other chronic diseases, we can create more opportunities for better healthcare worldwide.

Who We Are

Since its inception, Maxim has since acquired the Calypte's three product lines for screening and supplemental tests for HIV-1 antibodies. We carry reliable screening and supplemental urine tests for HIV-1 antibodies.

2005 – 2006

In May 2005, Maxim Biomedical was founded in Rockville, Maryland. Maxim Biomedical’s sister company, Maxim Biotech (founded in 1992) relocated from San Francisco, California to Rockville, Maryland. In 2006, Maxim Biomedical acquired Calypte Biomedical’s three product lines for screening and supplemental tests for HIV-1 antibodies.

2008 – 2011

In 2008, Maxim Biomedical began offering customized research and manufacturing services (CRO/CMO) and was able to successfully assist a client to obtain their first FDA Pre-Market Approved (PMA) Product. In 2011, Maxim successfully assisted a client receive their FDA Biological License Approved (BLA) Product.

2014 - 2015

Maxim Biomedical expanded their facilities and services to include 510K submissions and high volume, lateral flow production. Additionally, Maxim facilities have been upgraded to include brand new ISO 5 and ISO 7 laboratories, multiple dry rooms, and a Clinical Reference Lab.

Every Maxim product is manufactured according to U.S. Food and Drug Administration (FDA) Good Manufacturing Practice standards in our 30,000 square foot facility. The company also has U.S. FDA Certificates to Foreign Governments and Certificates of Exportability for our products. Maxim markets its products through a network of national and regional distributors.


Maxim Biomedical operates a 30,000 sq. ft. cGMP and ISO 13485 certified facility which is equipped to meet OEM manufacturing needs for the pharmaceutical and in vitro diagnostic product industry. See below for regulatory certificates.

Certificate of Analysis (COA)

Please see below for Maxim’s Certificate of Analysis of our most recent lot releases. For any previously released lots, please contact us.

Maxim Biomedical Flyers

Please find the following flyers for your references. You may find the flyers contain useful information for our products and services available. For general inquiries: Contact us.