As we detail below, specimen collection devices and kits are independently regulated as medical devices by FDA, and any clinical laboratory developing or performing LDTs must have a sound strategy ...

In a molecular diagnostic laboratory, having a system for tracking specimens, or assays, is integral to workflow efficiency and accuracy. Although streamlining this process often proves to be ...

A U.S. district judge foiled the Food and Drug Administration's plan put forth under the Biden administration to regulate lab ...

TALLAHASSEE, Fla. (WCTV) - The Guy Harvey Foundation is teaming up with the Gulf Specimen Marine Lab to give educators in the ...