Test Classification Current Value

This test was developed, and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Test Classification Value Prior to 2/15/2024 8:06pm

These assays were developed, and their performance characteristics have been determined by Quest Diagnostics. They have not been cleared or approved by FDA. These assays have been validated pursuant to the CLIA regulations and are used for clinical purposes.