IVD: In Vitro Diagnostic Products. These products are labeled "For In Vitro Diagnostic Use."

ASR: Analyte Specific Reagents. These reagents are labeled "Analyte Specific Reagents. Analytical and performance characteristics are not established."

CE: CE-marked products. CE-marked products are labeled for in vitro diagnostic use and can be traded throughout the EU.

RUO: Research Use Only Reagents. These reagents are labeled "For Research Use Only. Not for use in diagnostic procedures."

LUO: Laboratory Use Only Reagents. These reagents are labeled "For Laboratory Use Only."

IVD & CE: In Vitro Diagnostic Products and CE-Marked Products. These reagents comply with the IVD and CE classifications and are distributed worldwide for in vitro diagnostic use.

ASR & RUO: Analyte Specific Reagents & Research Use Only Reagents. These reagents are labeled ASR for distribution throughout the Americas and RUO throughout the rest of the world. These products comply with the ASR and RUO definitions above.