510(k)/EUA/LTD

DevLab bio is committed to supporting the development of your molecular or immunoassay and supporting regulatory submission with both 510(k) and Emergency Use Authorization (EUA) through the Federal Drug Administration (FDA) and with Laboratory Developed Test (LDT) development (510(k)-EUA-LDT). We provide validation support to meet Centers for Medicare and Medicaid Services (CMS) and Clinical Laboratory Improvement Amendments (CLIA) standards. We create and develop all documents and validation procedures based on CLSI guidelines.

Contact us today to discuss your 510(k)-EUA-LDT project goals.

  • Perform all necessary Development Testing for 510(k)-EUA-LDT
  • Prepare all Standard Operating Procedures (SOP)
  • Develop all necessary Protocols
  • Generate Data, Assist with validation, or Assist with Technology
  • Transfer to your Laboratory depending on your regulatory path
  • Prepare Submissions and correspondence with regulatory organization as necessary depending on your regulatory path
  • Clinical Trial Support utilizing partners