Global Regulatory Representatives

Shown below are our in-country representatives for regulatory affairs issues and incident reporting.

EUROPE - Authorized Representative
Emergo Europe
Prinsessegracht 20
2514 AP The Hague
The Netherlands
https://www.emergobyul.com/

Registrar/Certification Body

ARK Diagnostics, Inc. maintains ISO 13485:2016 certification and is audited every year by:

BSI Group America Inc.
Herndon, VA, USA
https://www.bsigroup.com/en-US/

Note: To access Package Inserts, Safety Data Sheets, Certifications, and Regulatory Clearance, go to the ARK™ Products and select the specific assay.

Quality Management System

ARK Diagnostics, Inc. is committed to an effective, certified quality management system and is fully compliant with the following Quality System Regulations:

ARK Diagnostics, Inc. seeks regulatory clearance in the United States and Internationally.