REGULATORY

The Tellimmune™ Card is a US-FDA registered, Class 1 Medical device with intended use to deliver a volumetric aliquot of blood plasma, collected from a fingerstick or other direct application of whole blood.  The Telimmune Card itself is not an in-vitro diagnostic test and does not directly deliver a diagnostic result.  Any Laboratory Developed Test, that is intended for use to deliver a diagnostic result, from plasma collected using the Tellimmune™ Card, must be developed, validated and performed by a Clinical Laboratory  that is registered in the US by the Centers for Medicare & Medicaid Services (CMS), under rules established in the Clinical Laboratory Improvements of 1988 (CLIA).