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Tag: Regulatory

Regulatory

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AbC-19 Rapid Antibody Test Science Behind Lateral Flow LFIA Development Case Study NALFIA LFIA Education Pharma LFIA Manufacturing Point Of Care MHealth Announcements Appointments Charity Investor Launch Publications Regulatory Smartphone Readers
March 3, 2020

Be IVDR ready to protect your assay and business

Learn about the key changes to the In Vitro Diagnostic Directive and the areas you should be actively considering.

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February 3, 2020

Grasp ‘Software as a Medical Device’ regulation for success in the US mHealth market

mHealth Software Regulation: part II: Regulations for mHealth in the USA, the largest diagnostic market.

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January 27, 2020

MHealth software is big business: understand regulations and be a leader in this area

mHealth Software Regulation: part I: European regulation surrounding the rapid growing mHealth market.

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November 12, 2019

Octylphenol ethoxylates (OPE) usage deadline looming

Octylphenol ethoxylates are now included in the Annex XIV of REACH. What does it mean for LFIAs that use OPEs?

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May 14, 2019

Rapid free light chain test granted registration in Brazil

Seralite®– FLC Serum granted registration by the Brazilian Health Regulatory Agency (ANVISA) Abingdon Health is pleased to announce Seralite® – FLC Serum has...

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June 5, 2017

Extensive Clinical Validation Study for Seralite®-FLC

A peer-reviewed scientific publication featuring detailed clinical validation of Seralite®-FLC has been published in the British Journal of Haematology and is now available...

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  • Company News
July 25, 2016

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...

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July 22, 2016

FDA registration and CE marking of new lateral flow immunoassay Reader, ADxLR5®

Abingdon Health announces FDA registration and CE marking of new lateral flow immunoassay Reader – ADxLR5® Abingdon Health is pleased to announce the...

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