News&Insights

Atlas Link Technology Co., Ltd., a innovative developer of diagnostic solutions, is proud to announce a significant market advancement. Our flagship product, the NOVAtest hCG, has been granted the EU IVDR CE Mark by the British Standards Institution (BSI). This prestigious certification (CE 2797) is a powerful endorsement of the NOVAtest's quality and versatility, authorizing its application for both professional clinical diagnostics and the consumer home-testing market.

Certification under the European Union's stringent In Vitro Diagnostic Regulation (IVDR) represents a critical milestone, as it meets a higher benchmark for clinical evidence, safety, and post-market surveillance. This ensures that the NOVAtest delivers unparalleled reliability, whether in the hands of a healthcare professional or a consumer.

A Benchmark of Trust from BSI
BSI is a world-leading certification body whose mark is a globally recognized symbol of quality and safety. Achieving certification from BSI under the demanding IVDR framework underscores Atlas Link Technology's unwavering commitment to manufacturing diagnostics that meet the most rigorous international standards.

Designed for Universal Confidence and Convenience
The dual-purpose certification for the NOVAtest One Step hCG Urine Test means it delivers a seamless, trusted experience across all settings. Healthcare providers can rely on its 99% accuracy for confident clinical decisions, while consumers benefit from the same lab-quality assurance in the privacy of their homes, with clear results in just 5 minutes. This breakthrough effectively bridges the gap between the clinic and the home, building a new standard of trust in early pregnancy detection.