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Posted: July 25, 2016
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Announcement: GMP compliant facilities and registration with U.S. FDA

Abingdon Health announces GMP compliant facilities and registration with U.S. FDA

Scope of Quality Management System extended

Abingdon Health announces the registration of its manufacturing facilities as GMP compliant, with the U.S. Food and Drug Administration (FDA), for the design, development and manufacture of lateral flow devices, and device readers for in vitro diagnostic medical use.

In addition, the Company’s Quality Management System certification encompassing ISO 9001:2008, ISO 13485:2003 and BS EN ISO 13485:2012, has been further extended to cover the design, development and manufacture of lateral flow devices, ELISA kits, reagents and device readers for in vitro diagnostic medical use.

The first product to benefit from this enhanced regulatory environment is the newly available lateral flow immunoassay reader – ADxLR5® which is now registered with the FDA and CE marked as a Class 1 Medical Device. The ADxLR5® has been developed as a next-generation technology designed to offer the user the most up to date features required for the most complex quantitative lateral flow applications as well as the benefit of touch screen technology, barcode scanning and enhanced connectivity features.

The launch of the ADxLR5® will support the growth and expansion of the Abingdon Health multiple myeloma assays, Seralite®– FLC serum. In addition, the ADxLR5® will also be provided as an OEM reader solution for those customers wishing to have a bespoke reader developed alongside the development of lateral flow assays. Using their core expertise Abingdon Health are now able to offer the complete solution to OEM customers to deliver lateral flow assays and customised state of the art readers suitable for sale in USA, European and other markets.

Marsha Leeman, Quality and Regulatory Affairs Director said “The registration of our manufacturing facilities as GMP compliant reaffirms Abingdon Health’s commitment to making the groups Quality Management system integral to the company’s core business principles both for our own assays and also for our OEM customers”

Fiona Kilvington, Head of Sales and Marketing, said: “The availability of the ADxLR5® Reader for our customers will provide improved connectivity and traceability features with unique icon driven software providing workflow solutions for Seralite®– FLC serum. Furthermore, we understand that this is an important solution for our OEM customers and GMP compliance will enable the development of lateral flow assays and reader solutions suitable for the USA market.”

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