Maxim Biomedical, Inc. (Maxim), located in the Rockville, Maryland, was founded in May 2005. 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. The HIV-1 Urine EIA [Human Immunodeficiency Virus Type 1 (Recombinant)] offers high concordance with existing blood-based tests for HIV-1 antibodies when supplemented by the Cambridge Biotech HIV-1 Western Blot Kit [Human Immunodeficiency Virus Type 1 (HIV-1)]. HIV-1 Urine EIA received an establishment license from the Food and Drug Administration on August 6, 1996, allowing the company to manufacture and sell the Calypte HIV-1 Urine EIA for use in professional laboratory settings, and on May 28, 1998, the FDA granted approval to Cambridge Biotech Corporation for a urine-based Western Blot supplementary test for HIV-1 antibodies. These two screening and confirmation products allow us to begin full commercialization of the first urine-based diagnostic algorithm for the detection of HIV-1 antibodies. Furthermore, our serum-based Cambridge Biotech HIV-1 Western Blot Kit allows laboratories to establish a definite status for samples that are positive or indeterminate by routine screening assays or newer rapid tests using serum as the substrates.
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.
Our mission at Maxim is to develop and market in vitro diagnostic testing solutions that make positive contributions to public health and healthcare worldwide. Our urine-based 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.
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MANAGEMENT TEAM
1. Joe Ma, President/CEO
2. Sophie Ma, VP Administration
3. Jason Hightower, QA Director
4. Evelyn Martins, QA Manager
5. Sun M. Yi, QC Manager
6. Cillia Prosper, Manufacture Manager
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