FREMONT, Calif., July 25, 2024 /PRNewswire/ -- Alamar Biosciences, a company powering precision proteomics to enable the earliest detection of disease, today announces that it has successfully achieved ISO 13485:2016 certification. This internationally recognized standard for quality management systems is specific to the medical devices industry and signifies Alamar Biosciences' dedication to providing the highest quality products and services to its customers..

。这一国际公认的质量管理体系标准专门针对医疗器械行业，标志着阿拉玛生物科学公司致力于为客户提供最高质量的产品和服务。。

The ISO 13485:2016 certification is a critical milestone for Alamar Biosciences, reflecting the company's rigorous quality control processes and adherence to the stringent regulatory requirements necessary for the design, development, and manufacture of medical devices. This achievement underscores Alamar Biosciences' commitment to excellence, safety, and continuous improvement..

ISO 13485:2016认证是Alamar Biosciences的一个关键里程碑，反映了公司严格的质量控制流程，并遵守了医疗器械设计，开发和制造所必需的严格监管要求。这一成就突显了阿拉玛生物科学公司对卓越、安全和持续改进的承诺。。

'We are proud to have achieved ISO 13485:2016 certification at such an early point in our company's history,' said Yuling Luo, Ph.D., Chairman, Founder and CEO of Alamar 'This certification is a testament to the hard work and dedication of our entire team. It demonstrates our commitment to maintaining the highest standards of quality and safety in our products, ensuring that we meet the needs of our customers and the regulatory requirements of the medical device industry.'.

阿拉玛公司董事长、创始人兼首席执行官罗玉玲博士说：“我们很骄傲能在公司历史上的这么早就取得ISO 13485:2016认证。这一认证证明了我们整个团队的辛勤工作和奉献精神。它表明了我们致力于保持产品的最高质量和安全标准，确保我们满足客户的需求和医疗器械行业的监管要求。”。

The certification process involved a thorough evaluation of Alamar Biosciences' quality management system, including detailed assessments of its policies, procedures, and practices. The successful certification confirms that Alamar Biosciences operates in compliance with the ISO 13485 standard, providing a strong foundation for its ongoing growth and innovation in the biotechnology field..

认证过程涉及对阿拉玛生物科学公司质量管理体系的全面评估，包括对其政策，程序和实践的详细评估。成功的认证证实，阿拉玛生物科学公司的运营符合ISO 13485标准，为其在生物技术领域的持续增长和创新奠定了坚实的基础。。

Alamar Biosciences is dedicated to advancing the field of proteomics through innovative research and development. The company recently commercialized the ARGO™ HT System and NULISA™ assays for fully automated and highly sensitivity detection of protein biomarkers from biofluids. With the ISO 13485:2016 certification, the company is well-positioned to continue its mission of powering precision proteomics to enable the earliest detection of disease..

阿拉玛生物科学公司致力于通过创新研究和开发推进蛋白质组学领域。该公司最近将ARGO™HT系统和NULISA™分析商业化，用于全自动和高灵敏度检测生物流体中的蛋白质生物标志物。凭借ISO 13485:2016认证，该公司处于有利地位，可以继续其为精密蛋白质组学提供动力的使命，以实现疾病的最早检测。。

About Alamar Biosciences, Inc.

关于Alamar Biosciences，Inc。

Alamar Biosciences is a privately held life sciences company with a mission to power precision proteomics to enable the earliest detection of disease. The company's proprietary NULISA Platform along with the ARGO HT System work seamlessly with the latest advances in genomics to achieve single digit attomolar detection sensitivity, greatly surpassing the most sensitive protein detection technology on the market today.

阿拉玛生物科学公司（AlamarBiosciences）是一家私营生命科学公司，其使命是为精密蛋白质组学提供动力，以实现疾病的早期检测。该公司专有的NULISA平台以及ARGO HT系统与基因组学的最新进展无缝结合，实现了单位阿托摩尔检测灵敏度，大大超过了当今市场上最灵敏的蛋白质检测技术。

For more information, please visit alamarbio.com..

有关更多信息，请访问alamarbio.com。。

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