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IVD products
A short overview

In-vitro diagnostics (IVD)

In-vitro diagnostics are medical products which, in line with the purpose determined by the manufacturer, are exclusively or mainly suitable for obtaining information through an in-vitro examination of specimens from the human body, including blood and tissue, this information being

  • on physiological or pathological conditions or
  • on congenital anomalies or
  • to check for safety or tolerance on the part of potential recipients or
  • to monitor therapeutic measures.

In-vitro diagnostics may include reagent products, calibration and inspection material, instruments, apparatus, devices and specimen containers.

The Hirschmann range of in-vitro diagnostic products includes the following:

  • Disposable capillary pipettes
  • Haematocrit capillaries
  • Glass covers
  • Counting chambers
  • Sealing wax plates

European Directive 98/79/EC on in-vitro diagnostics includes regulations governing the products which fall under this directive. Confirmation of compliance with the IVD directive is indicated by applying the CE symbol to the product and drafting a CE declaration of conformity. This confirms that the product meets the fundamental requirements of the IVD directive and that appropriate tests have been conducted.