Shown below are our in-country representatives for regulatory affairs issues and incident reporting.
ARK Diagnostics Inc. maintains ISO 13485:2003 certification and is audited every year by:
BSI Management Systems America, Inc.
Reston, VA, USA
Note: To access Package Inserts, Safety Data Sheets, Certifications, and Approvals, 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.