FDA-cleared HPLC diagnostic assays

Today, many of our customers don't have the time or resources to put together their own system or develop and validate a "home-brew" method for a critical clinical-diagnostic application and take it through the FDA 510(k) clearance process. We've done the work for you, delivering turn-key systems with all you need to achieve maximum performance: integrated components including instruments, columns, reagents, and, when appropriate, sample prep – along with expert chemistry, application, and service support. Our HPLC oncology systems, including the only FDA cleared system for plasma metanephrine, have been adopted by major clinical laboratories throughout the world to rule out potentially fatal chromaffin cell tumors – usually found in the adrenal glands – with far more sensitivity than traditional assays. Click on the links below to view our approved HPLC assays.

We also offer a number of research-only clinical-research assays – click here to learn more.