Dainippon Seiki Co., Ltd. is honored to announce the FDA registration of our “AS-410M” Auto Slide Preparation System, effective February 2024. This advanced device automates the sectioning of paraffin-embedded blocks, a process integral to pathology diagnosis that has traditionally required manual execution. By automating sample block sectioning, slide glass mounting, stretching, and drying, the AS-410M markedly enhances the efficiency and accuracy of specimen preparation.
Having obtained CE certification under the In Vitro Diagnostic Directive (IVDD) in 2016 and subsequently aligning with the In Vitro Diagnostic Regulation (IVDR), the AS-410M has established a significant presence in the EU medical device market. The recent FDA certification enables us to extend our market reach into the United States.
With the rising prevalence of cancer diagnoses globally, the necessity for efficient and reliable thin section preparation is paramount. The AS-410M is already in use in various medical institutions, pharmaceutical companies, contract testing organizations, and public research bodies globally, where it has demonstrated substantial improvements in specimen preparation efficiency.
Dainippon Seiki Co., Ltd. is dedicated to advancing the speed and precision of pathological diagnostics by mitigating workforce challenges and refining workflows through innovative automation.
For more information, check our product page at the link below:
AS-410M (dnseiki.co.jp/en)
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