Patient-like materials Lot-to-lot consistency Accuracy and Precision Ethical production Independent QC materials Multi controls Test Test

Ethical production

The human serum used in our products is collected from healthy, voluntary, and unpaid donors in accordance with European standards and regulations for blood bank services. Human-based additives are only sourced from reputable companies that can document the safe and ethical origin of the materials.

Acquisition and use of blood, blood products and other human components as raw materials for medical products is carefully regulated by Norwegian law, which is derived from a number of detailed EU directives. These
directives are designed to protect the health and human rights of both donors and potential recipients of therapeutic blood products and also regulate the use of products as raw materials for IVD products. According
to these directives it is prohibited to use blood donated from diabetics treated with insulin as raw material to produce a quality control with elevated levels of HbA1c. SERO has chosen to offer an ethical alternative
to other HbA1c controls on the market by producing a HbA1c control by in vitro glycation of human hemoglobin from healthy blood donors.

As the most important use of safe human blood products is for the treatment of patients, there is an unmet medical need for such products in many countries. Thus in line with recommendations from the WHO and
medical authorities, and to give our customers an ethical choice, SERO also produces animal-based control sera when such products show full technical compatibility with human products for use as control materials.
All animal raw materials are collected from veterinary-certified healthy animals at Norwegian facilities which are government approved according to EU-regulations.

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