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Avacta Group PLC - developer of diagnostics and cancer therapies - Life Sciences diagnostics unit gets ISO 13485 certification for the quality management system for the manufacture and distribution of Affimer reagents for use in lateral flow, ELISA and immunodiagnostic in-vitro diagnostic devices.
"The ISO 13485 standard defines the comprehensive requirements for quality management for a developer and legal manufacturer of diagnostic products and medical devices," company explains.
It adds: "ISO 13485 certification means that the CE mark for the AffiDX SARS-CoV-2 antigen lateral flow test can be transferred to Avacta from its partner, Mologic, and Avacta will be legal manufacturer of all future in-vitro diagnostic products."
Chief Executive Alastair Smith says he is "delighted" to secure the certification.
"ISO 13485 certification is recognised globally by our partners, customers and regulatory bodies alike as the medical device industry benchmark for quality. This certification marks a major milestone for Avacta and underpins the product development strategy for the future of our diagnostics division," he adds.
Current stock price: 143.69 pence, up 6.0% on Wednesday
Year-to-date change: up 26%
By Paul McGowan; paulmcgowan@alliancenews.com
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