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Developer and Manufacture of In-Vitro Diagnostic ELISA test Kits

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Our Company

HEADQUARTERED in Miami, FL, BioDominium Diagnostics is an American manufacturer of diagnostic test reagents for infectious and autoimmune diseases. BioDominium prides itself with raising the bar to what medical laboratories can expect from test manufacturers.

Among its founders, a research scientist with nearly four decades of experience in the medical device industry, who pioneered the development of in-vitro diagnostic enzyme immunoassays for the diagnosis and management of infectious and autoimmune diseases.

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Quality Products

BioDominium Diagnostics’ objective is to manufacture quality products for companies lacking the manufacturing capabilities, but requiring direct specifications for their IVD’s products, while in turn allowing the company proper ownership of their products.

  • The bulk of our products are made from US raw materials
  • Contract manufacturer conforming
  • Products designed and developed for either manual use or used on fully automated instrument.
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EIA Product Line

Infectious Diseases

  • ToRCH
  • Early Childhood Diseases
  • Epstein-Barr Panel
  • Syphilis
  • H. pylori
  • Respiratory Diseases

Autoimmune

  • Rheumatic Diseases

NeoNatal

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Product Feature

  • Common Assay Protocols throughout Product Line
  • Incubation at Room Temperature or 37° C
  • All Reagents Ready for Use (except Wash Concentration)
  • Ease of Automation
  • Tests Validated on Multiple Automated Analyzers
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Service and Support

  • Technical Support Staff
  • Lot Sequestering
  • Proficiency Panels for Product Validation
  • Post-Market Surveillance
  • Vigilance Programs
  • Inventory Control


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Our Facilities

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Contact us

BioDominium Diagnostics

7440 SW 50 Terrace
Suite 110
Miami, FL 33155
Tel (+1) 305-362-8595
Fax (+1) 305-370-3151

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Please visit us again soon for more products and services. Thanks