News&Insight

Atlas Link Technology Co., Ltd. is pleased to announce that its NOVAtest® One Step LH Urine Test has successfully obtained certification under the European In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). The certification was issued by BSI (British Standards Institution), confirming the product's conformity with the applicable European regulatory requirements for both professional use and self-testing applications.

The successful IVDR certification marks another significant milestone in Atlas Link Technology's commitment to developing reliable, user-friendly, and internationally compliant diagnostic solutions. The certification reflects the NOVAtest® LH's conformity with the enhanced requirements of the IVDR framework, including product safety, analytical and clinical performance, risk management, technical documentation, and post-market surveillance.

Supporting Smarter Ovulation Tracking

The NOVAtest® One Step LH Urine Test is designed to detect the surge of luteinizing hormone (LH) in urine, an important indicator associated with the fertile window. By providing a convenient way to monitor LH levels, the test can help users better understand their ovulation cycle and identify the most relevant period for fertility planning.

For healthcare professionals, the test provides a practical tool for fertility-related assessment and monitoring. For consumers, its self-testing format offers a convenient and accessible way to perform testing at home, without the need for specialized equipment or laboratory facilities.

Quality and Confidence Backed by BSI

Certification by BSI, a globally recognized standards and certification organization, provides independent assurance that the NOVAtest® LH meets the applicable requirements of the EU IVDR. This achievement demonstrates Atlas Link Technology's continued focus on product quality, regulatory compliance, and performance throughout the product lifecycle.

By achieving IVDR certification, the NOVAtest® LH joins Atlas Link Technology's growing portfolio of internationally certified IVD solutions, strengthening the company's ability to support partners and customers in the European and global markets.

Convenient Testing for Professional and Home Settings

Designed with simplicity and accessibility in mind, the NOVAtest® One Step LH Urine Test provides a straightforward testing experience for users across different settings. Its self-testing capability allows consumers to incorporate LH testing into their personal fertility tracking routines, while its professional-use application provides healthcare professionals with an additional tool for fertility-related testing.

The successful certification of NOVAtest® LH further demonstrates Atlas Link Technology's commitment to bringing dependable diagnostic technologies closer to users. As the company continues to expand its global IVD portfolio, Atlas Link Technology remains focused on combining regulatory compliance, product innovation, and user-centered design to deliver accessible diagnostic solutions for healthcare professionals and consumers worldwide.