ADSTEC along with its subsidiary ADS Biotec now offer a range of HANABI Cytogenetic Automation Instruments with CE-IVD mark.
September 27, 2022 –Tokyo, Japan and Omaha, USA: ADSTEC and its subsidiary ADS Biotec, a global leader in development of automated instruments and consumables for use in cytogenetic, pathology and research laboratories is pleased to announce that a range of its HANABI Cytogenetic Automation Instruments received CE Marking under the European Union In Vitro Diagnostic Medical Device Directive (IVDD) 98/79/EC in May of this year. This regulatory milestone allows the company to offer CE-IVD marked HANABI instruments for clinical diagnostic use in hospitals, laboratories and clinics across Europe and other markets that recognize this registration as valid regulatory acceptance for in vitro diagnostic use.
ADSTEC has obtained CE-IVD regulatory clearance for a range of HANABI instruments including P1 & P2P Metaphase Chromosome Harvesters, P5 Metaphase Chromosome Spreader, and S1020 Auto Chromosome Staining System. All of these instruments will now be offered in Europe with CE-IVD marking, complying with the effective In Vitro Diagnostic Medical Device Directive (IVDD) and also in line with the future In Vitro Diagnostic Regulation (IVDR) requirements.
”Achieving CE-IVD registration demonstrates our continued commitment to meet our customer needs for novel automation solutions for Cytogenetics and Pathology markets”, said Yuki Kojima, President of ADSTEC Corporation. “Our HANABI products are designed, manufactured and tested in accordance with ADSTEC design controls, quality systems and applicable verification and validation procedures that are required of in vitro diagnostic medical devices”.
”Compliance with the relevant EU legislation and ADSTEC’s attainment of the CE-IVD mark represents ADS Biotec’s commitment to developing and marketing in vitro diagnostic medical devices that meet stringent regulatory requirements”, said David Hild, Sr. Vice President and GM of ADS Biotec. “With total focus and commitment to quality, we are dedicated to expanding our quality system and regulatory acumen to meet market access requirements in the evolution of regulatory jurisdictions”.
HANABI Cytogenetic Instruments with CE-IVD marking are available immediately for customer delivery.
About ADS Biotec
ADS Biotec, along with its parent company ADSTEC, is a global leader in the development, manufacture and sale of automated instruments and consumables for use in cytogenetic, pathology, molecular biology and research laboratories. Our flagship HANABI Metaphase Chromosome Harvesters and Spreaders designed for use by cytogenetic laboratories provide increased productivity and automated throughput with reliable and consistent quality. Our high quality RNA buffers and columns are used by leading Pharmaceutical and Biotech companies. ADS Biotec has a global presence with development, sales, and support operations on three continents, and supports system users in over 30 Countries. We are recognized by our customers for our advanced instrumentation, superior customer service, scientific application support, and its very knowledgeable sales force.
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