CE marked controls

Our CE – marked controls fulfil the require-
ments of the European In-Vitro-Diagnostics Directive 98/79/EC and are suitable for internal quality control in medical diagnostic laboratories.

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Customized controls

BIOREF GmbH has a great expertise in the production of tailor-made controls for immuno-
assays serving the specific needs of the customer.

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Diagnostics should not be a game.

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BIOREF GmbH is since more than 30 years a privately owned company dedicated to development, production and distribution of quality controls for immunoassays.

Our laboratories and offices are located 50 km east from Frankfurt / Main – quite in the middle of Germany.

The QM system is certified according to ISO 9001 and ISO 13485. Surveillance is performed by MDC medical device certification GmbH (Stuttgart, Germany).

BIOREF performs continuously research and development projects – e.g. BIOREF conducts proficiency studies for diagnostic tests in collaboration with experts in the field of laboratory medicine. These studies have been published in several journals.