— Research Solutions —
Your HIV Solution Center
About Us
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 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.
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.
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.
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.
ABOUT US
2019-09-25
Maxim Biomedical attends the FDA's Small Business Regulatory Eduation for Industry (REDI) conference in Bethesda, Maryland.
2017-08-30
Maxim Biomedical, Inc. becomes the first company in the nation to be CDC approved for HIV-1 LAg-Avidity DBS and Serum/Plasma EIA Kits.
2015-04-25
Maxim Biomedical and Calypte Biomedical announce new distribution agreement for purchase of both Maxim's HIV-1 Limiting Antigen (LAg)-Avidity EIA Kit and Calypte's Aware BED EIA HIV-1 Incidence Test.
2013-02-08
Our annual renew audit for ISO 13485:2003 was performed and approved by G-MED.
2012-12-27 ~ 2013-01-07
Our bi-annual audit for FDA cGMP Certification was conducted.
2012-12-12 ~ 2012-12-14
Maxim presented our "New HIV-1 LAg-Avidity EIA Kit- Incidence Study" poster and flyer during the 2012 HIV Diagnostics Conference held in Atlanta, GA from 12/12/2012 to 12/14/2012.
2012-12-01
World AIDS Day!
In conjuction with World AIDS Day, Maxim has announced the launch of our CDC approved new HIV-1 LAg-Avidity EIA product (P/N: 92001).
2012-09-21
Maxim representatives attend University of Maryland Career Fair
2012-05-01
Maxim released 3 newly developed R&D Western Blot (WB) kits, NOT for In Vitro Diagnostic Use in USA:
1. Max1 HIV-1 Serum/ Plasma/ Dried Blood Spot WB Kit, P/N: 98201
2. Max1 HIV-1 Oral Fluid WB Kit, P/N: 98202
3. Max1 HIV-1 Urine WB Kit, P/N: 98203
2012-01-19~2012-01-20
A renew audit for ISO 13485:2003 was performed and approved by G-MED.
2011-12-01
Sigend a contract manufacture agreement to produce a biomarker CLIA (CheminoLumiscence ImmunoAssay) kit related to onset of Sepsis.
2011-11-18
A contract manufactured Recombinant ImmunoBlot Assay (RIBA) product received BLA approval from FDA.
2011-11
Signed a contract manufacture agreement to produce a HIV-1/2 rapid test.
2011-05
License multiple technologies from CDC for new products development.
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Help us solving HIV for future generations
Maxim Biomedical (Maxim), as your HIV solution center, provides the following products:
A. FDA APPROVED PRODUCTS:
Western Blot (WB)--
98002, Cambridge Biotech HIV-1 Serum Western Blot Kit, 27 Tests
98078, Cambridge Biotech HIV-1 Urine Western Blot Kit, 27 Tests
Enzyme Immunoassay (EIA)--
700000, Maxim HIV-1Urine EIA kit, 480 Tests
700010, HIV-1 Oral Fluid EIA Kit, 9600T
700020, HIV-1 Oral Fluid EIA Kit, 960T
700030, HIV-1 Oral Fluid EIA Kit, 384T
700040, HIV-1 Serum/ Plasma EIA Kit, 9600T
700050, HIV-1 Serum/ Plasma EIA Kit, 960T
700060, HIV-1 Serum/ Plasma EIA Kit, 384T
B. CDC APPROVED PRODUCTS:
92001, Maxim HIV-1 Limiting Antigen Avidity (LAg-Avidity) EIA Kit
92003, Maxim HIV-1 Limiting Antigen Avidity (LAg-Avidity) EIA, Dried Blood Spot (DBS) Kit
C. Maxim R&D PRODUCTS (NOT for in vitro diagnostic use in USA):
Western Blot (WB)--
98201, Maxim HIV-1 Serum/ Plasma Western Blot Kit, 27 Tests
98202, Maxim HIV-1 Oral Fluid Western Blot Kit, 27 Tests
98203, Maxim HIV-1 Urine Western Blot Kit, 27 Tests
Enzyme Immunoassay (EIA)--
700120, Maxim Human IgG Quantitative EIA Kit (Coming Soon)