Quality Certifications
ISO 9001:2015 & ISO 13485:2016 REGISTRATION/CERTIFICATION:
The Quality Management System that we have implemented and maintain fulfills the requirements of the ISO 9001:2015 and ISO 13485:2016 standards as documented, through audits, by Perry Johnson Registrars, Inc.
Our Quality System Scope under ISO 9001:2015:
- Design, Development, Manufacture, and Sales of Test Kits and Components for Environmental, Food Safety, and Life Sciences
Our Quality System Scope under ISO 13485:2016:
- Design, Development, Manufacture, and Sales of Test Kits and Components for Environmental, Food Safety, and Life Sciences
- Product Category: In Vitro Diagnostic Medical Devices: Reagents, Reagent Products, Calibrators and Control Materials
Click to view a copy of our ISO 9001:2015 and ISO 13485:2016 certificates.
Our Company
In November 2017, Abraxis, Inc. joined Eurofins Technologies, the diagnostic kit manufacturing division of Eurofins Scientific, an industry leader in laboratory testing services and was renamed Eurofins Abraxis.
Beginning December 1, 2022, Eurofins Technologies initiated a rebranding of their business lines, including Eurofins Abraxis, to Gold Standard Diagnostics. This change reflects our recent evolution and the further ambitions to become an innovative and trusted solution provider for all of our stakeholders, and to simplify and improve the customer experience.
The Gold Standard Diagnostics brand was established a few years ago, across multiple businesses, for the Eurofins Technologies clinical product line. We are now extending this branding to our entire test kit, reagent and instrument development and manufacturing businesses. We are becoming one strong and unified team, under the same name and brand, across businesses, regions and applications.
About Gold Standard Diagnostics
For over 20 years, Gold Standard Diagnostics Horsham (formerly Eurofins Abraxis) has developed, manufactured, and marketed rapid environmental, food, and life sciences test systems to meet the testing needs of research and industry. We collaborate with global government, industry, and academic leaders to develop innovative methods and applications to respond quickly to our customers’ requests for assays when new threats (e.g. harmful algal blooms, melamine, glyphosate in foods) arise. Many of our products are validated/verified by agencies such as US EPA, USDA, USGS, FDA, Japanese Ministry of the Environment, and WHO. We hold, or are exclusive licensee, of several key technology patents, with additional applications in process.
Why Gold Standard Diagnostics?
Our scientific staff has experience with medical, industrial, and environmental testing. We are able to customize programs to serve the client’s specific needs with competitive pricing and high quality standards. Gold Standard Diagnostics Horsham is headquartered in the United States and serves our customers, directly or through distributors, in over 100 countries around the world.