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Certifications and Licenses

Lee BioSolutions is a cGMP-compliant laboratory as well as a certified and licensed ISO, FDA, EPA and USDA producer and supplier of high purity human, animal and recombinant proteins, biological fluids and tissue, fine biochemicals, antibodies, coenzymes, cofactors and biomarkers. The biotechnology company specializes in the development, manufacturing and purification of high-quality tumor, cardiac, stomach, renal and liver biomarkers. Lee also is 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.

Biological Materials Supplier Certifications

  • ISO 9001:2008 Certified Biological Materials Supplier
  • FDA Registered Biological Materials Supplier No: 3004343130
  • FDA Registered Establishment: IVD Manufacturer
  • FDA Registered Products: Certified to prepare, store and distribute blood products for diagnostic use
  • USDA Certified Biological Materials Supplier

Environmental Permits

  • Environmental Protection Agency (EPA) Permit No: MO-D077148492
  • Missouri Clean Water Act-Missouri State Operating Permit No: MO-R23A070
  • Metropolitan Sewer District Permit No: 11185469-00

Business Licenses

  • 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
  • Brentwood Business License No: 0552

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