New IVDR Self-Testing Certificate for Strep A Rapid Test!

Release date:17/03/2025

We are excited to announce that Greylynx, a subsidiary of VivaChek, has successfully received the In Vitro Diagnostic Regulation (IVDR) self-testing certificate for its Strep A Rapid Test. This certification ensures our commitment to providing an accurate, reliable, and user-friendly diagnostic solution for early detection.

The IVDR (EU 2017/746) establishes a robust, transparent, and sustainable regulatory framework to enhance clinical safety and expand market opportunities for healthcare professionals and manufacturers.

✅ Key Benefits of the Strep A Rapid Test:

Fast & Reliable – Results in just 5 minutes with high sensitivity.
Easy to Use – Requires no equipment and minimal training.
Convenient – Self-testing kits allow quick and accurate results.
Versatile – Suitable for home use, workplaces, and healthcare settings.

Our New IVDR Certification for Strep A Rapid Test marks another step in VivaChek’s mission to deliver high-quality point-of-care testing solutions to improve global healthcare.