Archive for: Laboratory Developed tests

  • ORIGINAL ANALYSIS

  • PDF DOWNLOAD

  • EXTERNAL LINK

  • POST

Diagnostics

FDA is allowing for high complexity laboratory developed tests for COVID-19 testing.

Based on its review of the evidence, FDA has concluded that molecular-based laboratory developed tests (LDTs) that are authorized for use by the singular developing laboratory are appropriate to protect the public health or safety.

POST

beakernav X1E2BFA62-BFCE-43C1-B777-27E3E5216018medical bagoriginal analysis +external linkpdf downloadstethoscope