Certificate ensures conformity of Quality Management System within IVD Directive

LAKE FOREST, CALIFORNIA – October 28, 2011 – Monobind Inc. has received a CE-Certificate for its complete PSA product family (consisting of Annex II List B Devices: PSA ELISA, PSA CLIA, Free PSA ELISA, Free PSA CLIA, Cancer VAST ELISA, Cancer VAST CLIA and Multi-Ligand Control), demonstrating conformance with the In Vitro Diagnostic Directive 98/79/EC and its ability to consistently deliver medical device products and services that meet customer and regulatory requirements.

“This is a significant and long awaited milestone in commercializing our PSA products worldwide, critically in Europe. The CE Marking of Conformity Certificate signifies we have met the clinical, quality, and performance requirements of the MDD-Directive, including the conformance of our quality systems and Technical Documentation to the rigorous performance.” Alicia Jerome Volkov, Marketing Director.

The Certificate was issued by NSAI, an Irish Notified Body, in accordance with Annex IV of the Medical Device Directive, under Registration Number 304.1006 and is valid until October 27, 2014. It is available upon request from Monobind.

Monobind also maintains its Quality System to ISO 13485: 2003 and 9001:2008 standards. NSAI has registered Monobind under certificate number A2163US. Additionally, Monobind is an FDA registered establishment under 2020726. To view Monobind’s Quality Certifications, registrations and other relevant licenses, please see visit the Customer Support Area.