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ZeptoMetrix Quality Control Products Receive IVDR Certification

NEW YORK – ZeptoMetrix announced on Tuesday that it has received certification under Europe's new In Vitro Diagnostic Regulation for the majority of its quality control products. 

The Buffalo, New York-based firm received an IVDR Quality Management System certificate from notified body British Standards Institution. The certificate applies to the majority of its CE-marked NATtrol quality control products for molecular diagnostics, it said in a statement. NATtrol products are prepared from purified microorganisms grown in cell culture, in microbial culture, or isolated from the plasma of infected people, according to the company's website. 

ZeptoMetrix, a subsidiary of Antylia Scientific, will focus on the implementation of updated product labeling over the next several months now that the certification has been achieved, it said. ZeptoMetrix provides external quality controls, verification panels, proficiency panels, and customized and original equipment manufacturing products and services for the infectious disease diagnostics market. 

The transition to IVDR reflects the company's "continuous investments in quality programs, regulatory compliance, and demonstrates our ongoing quality commitment to our partners and customers," Glenn Harrall, the firm's global VP of quality, said in a statement.