IVDR promotes high levels of safety and quality while supporting innovation - focus on patient safety.
Due to our early activities in order to get IVDR compliant, we and service laboratories, who are using our products to diagnose patients, play a part in contributing to no shortages in in vitro diagnostic products and therefore patient care is secured.
We submitted the technical documentation of the first tranche of our RealFast Assays and StripAssays to the Notified Body TÜV Süd and successfully received IVD CE0123 approval.
This means, that we now offer you the following products designed and developed under IVDR and this list is steadily growing:
- 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 implementing ViennaLab assays in your diagnostic laboratory you do not have to invest time into creating technical documentation, demonstrating scientific validity, generating analytical and clinical data, performance data, etc. as these are time- and cost-intensive tasks and are all covered by ViennaLab as an IVD manufacturer, which is confirmed by the certificate issued by the Notified Body TÜV Süd. View this link here.
So, having selected ViennaLab as your supplier of diagnostic products, lie back and relax.