FDA REGISTRATION

Telimmune™ cards are an FDA class 1 medical device, for research only, intended for direct plasma collection. In some countries, it may be used as a component of laboratory-developed tests (LDTs) after the laboratory has validated its complete system with relevant rules and regulations. 

 

The Telimmune card itself does not deliver a diagnostic result. The use of samples collected using the Telimmune card with LDTs requires laboratory establishment of diagnostic performance characteristics and successful validation of the diagnostic process in compliance with regulations applicable in the country of use.