Quality Certifications & Licenses

Lee BioSolutions is ISO 13485, ISO 9001 and USDA certified and registered with the FDA. We are a producer and supplier of high purity finished human and  animal proteins, biological fluids and tissue, recombinant proteins, antibodies, coenzymes, cofactors and biomarkers. We specialize  in the development, manufacturing and purification of high-quality tumor, cardiac, stomach, renal and liver biomarkers and related enzymes and proteins.  We are a  major manufacturer of human and animal enzymes and proteins for lipids, urinalysis, bilirubin and multi-analyte controls and calibrators, acute phase proteins, coagulation proteins and immunoassay biomarkers. Clients come to us for products that need to follow GMP guidelines.


  • ISO 9001 Certified
  • ISO 13485 Certified
  • FDA Registered Biological Materials Supplier No: 3004343130
  • FDA Registered Establishment: IVD Manufacturer
  • USDA Certified Biological Materials Supplier
  • APHIS Reference NO: MO-INT-0002

Business Permits and Identifications

  • SIC Code: 2835
  • NAICS: 325413
  • FIN: 75-2976103
  • Duns: 11-884-3130
  • Missouri Tax ID No: 18144489
  • Missouri Charter No: 504162
  • St. Louis County License No: MO141344A