Corgenix has over 20 years of experience in the IVD Industry with product development, manufacturing, regulation, and distribution. Our expertise enables us to guide our contract manufacturing partners to achieve the peak efficiencies in product manufacturing. We offer the complete production process, which can be aligned to your specifications.

Our Capabilities

  • Key raw material identification and sourcing
  • Approved vendors, second vendor validation, and qualification
  • Environmentally-controlled critical production processes
  • Automated filling and labeling of product components
  • Component capping with torque check
  • Custom-designed labels, utilizing in-house computerized label design and printing
  • Custom packaging
  • Paper or CD duplication of instructions for use
  • Lyophilization
  • In-process Quality Control testing
  • Final Kit Assembly

Additional offerings by Corgenix Contract Services for a complete contract manufacturing package include the following: 

  • Reagent application and validation on commonly-used laboratory instrumentation
  • Technical transfer of the contract-manufactured test kit
  • Small-scale Pilot-Lot production and testing for validation of test kit performance
  • Rapid scale-up of lot sizes for routine production and growth
  • Real-time inventory control

If you would like more information on our line of products or additional technical information please visit our technical information website at