What are some of the requirements for coding inclusion into the PLA section?


A variety of manufacturers have received approval for PLA codes that are applicable to the Microbiology department, including Accelerate Diagnostics, Inc., GenMark Diagnostics, Karius Inc., GeneX Inc., and BioRad Laboratories, RealTime Laboratories, Inc., and MIcroGenDX. The main standards for inclusion in the PLA section are:

  • The test must be commercially available in the United States for use on human specimens, and
  • The clinical laboratory or manufacturer that offers the test must request the code.

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