The EU IVDR 2017/746 directive, commonly referred to as IVDR, provides high levels of patient safety and quality while promoting innovation.
To avoid shortages of in-vitro diagnostic products at service laboratories when the IVDR directive is enforced, ViennaLab has initiated the transition of its products to IVDR by submitting the technical documentation for the first tranche of our RealFast™ Assays and StripAssays® to the Notified Body TÜV Süd and successfully obtaining approval.
This means that we now offer you the following products developed and produced under IVDR:
- alpha-Globin StripAssay [REF 4-160]
- CAH StripAssay [REF 4-380]
- CF StripAssays [REF 4-410, 4-420, 4-430, 4-440]
- FMF StripAssay [4-230]
- FMF-SAA1 StripAssay [REF 4-390]
- HLA-B27 RealFast Assay [REF 7-620/7-623]
By using ViennaLab assays in your diagnostic laboratory, you save valuable time and resources. There is no need to create technical documentation, demonstrate scientific validity, or generate analytical, clinical, and performance data—tasks that are both time-consuming and costly. As an IVD manufacturer, ViennaLab takes care of all these requirements, as confirmed by the certificate issued by the Notified Body TÜV Süd. View this link here.
So, after selecting ViennaLab as your supplier of diagnostic products, you can sit back, relax, and diagnose.