Shown below are our in-country representatives for regulatory affairs issues and incident reporting.
ARK Diagnostics, Inc. maintains ISO 13485:2016 certification and is audited every year by:
BSI Group America Inc.
Herndon, VA, USA
Note: To access Package Inserts, Safety Data Sheets, Certifications, and Regulatory Clearance, go to the ARK™ Products and select the specific assay.
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.