Predictive Technology Group Inc (PRED)

[Mr. Mercedes]

FDA authorizes blanket EUA for high-complexity labs!
PRED'S lab is CLIA certified
https://www.fda.gov/media/137470/download
"I have concluded, pursuant to section 564(d)(1) of the Act, that the scope of this authorization is
limited to devices that meet the authorization criteria set forth below when used in laboratories
certified under CLIA, 42 U.S.C. 263a, to perform moderate or high complexity tests as an aid in
identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or
prior infection, by detecting antibodies (IgG, or IgG and IgM, or total), as specified in each
authorized device’s instructions for use, to SARS-CoV-2 in human plasma and/or serum during
the COVID-19 pandemic"
Manufacturers must submit clinical agreement data from an independent validation study
performed by the NCI, or by another government agency designated by FDA
RADM Denise M. Hinton
Chief Scientist
Food and Drug Administration