Qiagen - FDA 510(k) Cleared Devices

Qiagen, is a global life sciences company offering sample-to-insight solutions for molecular diagnostics, research and clinical applications. The company serves over 500,000 customers worldwide with products spanning nucleic acid extraction, PCR systems, sequencing, and bioinformatics platforms. Qiagen operates with a manufacturing facility in Germantown, US.

Qiagen has received 1 FDA 510(k) clearance from 1 total submission. The company's regulatory focus centers on Microbiology devices, with its cleared device being the artus HSV-1/2 QS-RGQ MDx Kit. The clearance was granted in 2014. Qiagen has not submitted new 510(k) applications in over five years and is considered inactive in the FDA clearance database.

This profile represents a historical regulatory record. For current product information and FDA clearance details, explore the device names and submission dates in the database.

510(k) submissions have been managed by Qiagen Gaitherburg as regulatory consultant.