Predictive Technology Group Inc (PRED)

[Juice McJuicerson]

Since you're too lazy to scroll.

A: As stated in Section IV.D of the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019, the FDA does not intend to object to the development and distribution by commercial manufacturers, or development and use by laboratories, of serology tests to identify antibodies to SARS-CoV-2, where the test has been validated, notification is provided to FDA, and information along the lines of the following is included in the test reports:

The commercial manufacturers and laboratories listed below have notified FDA that they have validated and are offering serology tests as set forth in Section IV.D of the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019. The FDA has not reviewed the validation of tests offered by these developers, who will not be pursuing EUAs, and is including this list here to provide transparency regarding the notifications submitted to FDA.

Healgen Scientific, LLC. COVID-19 IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma)
INNOVITA (Tangshan) Biological Technology Co., Ltd. 2019-nCoV Ab Test (Colloidal Gold)
Jiangsu Dablood Pharmaceutical Co, Ltd. AssuranceAB™ COVID-19 IgM/IgG Rapid Antibody Test
Jiangsu Dablood Pharmaceutical Co. Ltd. COVID-19 IgM/IgG Rapid Test
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. SARS-CoV-2 IgM/IgG Rapid Assay Kit (Colloidal Gold)
Lifeassay Diagnostics (Pty) Ltd Test-it COVID-19 IgM/IgG Lateral Flow Assay
Liming BioProducts Co. Ltd. SARS-CoV-2 lgM/lgG Antibody Rapid Test