IVD Genetic Tests According to the European Union Directive (98/79/EC) In Vitro Diagnostic Medical Device (IVD) CE marking is required in case manufacturer is intending the use of it's products for diagnostic use in European Union. Genorama IVD CE certified tests are non-invasive and easy-to-use DNA analysis tools developed for certain genetic disorders diagnostics in clinical practice. All IVD tests are profoundly validated and enable the results interpretation. Information behind each variation is controlled and veritable.
Applications:
- Confirmation of the diagnosis
- Carrier status screening
- Prenatal diagnosis
- Family planning
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