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Specialty Diagnostics, Inc.
Clinical Genetics Center
A State Licensed High Complexity Laboratory
Our RAPID Antigen Test has undergone clinical validation studies in our high-complexity CLIA certified laboratory. It has also undergone independent validations in other 3rd party labs. Please make sure all regulatory documents are executed.
SDI’s 15 Minute SARs-CoV-2 Antigen Test Device is a laboratory-based Antigen Test (LDT) and is Made in the USA. It is legally approved to be administered in the USA through only our high complexity laboratory channel. Our laboratory clinically validated the 15 Minute SARs-CoV-2 Antigen Test using the Laboratory Developed (LDT) pathway which is governed by the U.S. Dept. of Health and Human Services (HHS) and permits the use of our SARs-CoV-2 Antigen Test in the USA.
New packaging coming soon!