Quality & Regulatory

Lee Biosolutions is ISO 13485, ISO 9001,  USDA certified and registered with the FDA. We are a major producer and supplier of high purity human and  animal proteins, biological fluids , recombinant proteins and  antibodies used as critical raw materials in the IVD industry and academic research.   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.    .


  • ISO 13485-2003 Certification
  • 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