In Vitro Diagnostics (IVD) General

Products for laboratory tests (in-vitro diagnostics) in not device-specific, general areas.

All of our in-vitro diagnostics (IVD) are compliant with the European IVD Directive 89/79/EG and are labelled with the CE mark.

Bioanalytic GmbH has a quality management system (QMS) and operates according to the following standards:

  • DIN EN ISO 13485 / IVD-Directive 98/79/EG.
  • DIN EN ISO 09001

We guarantee for perfect function of our reagents until the expiry date stated on the label. Our products are produced for the use referred in the description and are subject to a continuous quality control.