Modification of In Vitro Diagnostic Devices: Leveling the Playing Field

Clin Chem. 2020 Jun 1;66(6):760-762. doi: 10.1093/clinchem/hvaa076.
No abstract available

Keywords: FDA; laboratory developed test; modification.

MeSH terms

  • Clinical Laboratory Techniques / instrumentation
  • Clinical Laboratory Techniques / methods*
  • Clinical Laboratory Techniques / standards
  • Humans
  • Laboratories / standards
  • Reagent Kits, Diagnostic / standards*
  • United States
  • United States Food and Drug Administration

Substances

  • Reagent Kits, Diagnostic