We are very pleased to announce that we have received an EU Quality Management System Certificate under Regulation (EU) 2017/746 (IVDR). This certificate covers our Newbio TPHA and Newbio RPR product ranges (class C devices).
We will be transitioning to supply IVDR labelled products to our distributors and customers over the coming months so please look out for these exciting changes.
PK-TPHA product for use on PK7300 will not be certified under the IVDR. However, an updated product will be available as Class D certified for use on the PK7400 analyser through Beckman Coulter, this Certification is ongoing.
SYPHILIS EIA Total Antibody, there are no plans to certify this product under the IVDR.