Ikonisys, Inc

Contact: Paul White - President
Address: 5 Science Park, New Haven, Connecticut 06511, USA
Phone: +1-(203)-776-0791 | Fax: +1-(203)-776-0795 | Map/Directions >>

Profile: Ikonisys, Inc. enables early, accurate, disease and genetic disorder detection. Our products enable large and regional reference labs, hospitals, research institutions and practice groups to reduce the risk of human error. Our CellOptics® platform is the foundation for the highly accurate, automated diagnostic tests we offer, and represents the fusion of cell and molecular biology, microscopy imaging, artificial intelligence and informatics. It provides the tools and protocols to create seamless, highly integrated procedures for automated and unattended cell based diagnostic products. We provide Fastfish® for the prenatal detection of genetic disorders and Oncofish® for cancer diagnostics and monitoring.

FDA Registration Number: 3005566046

5 Products/Services (Click for related suppliers)  
• Analyte Specific Reagents, Asr Reagents (FDA Code: MVU / 864.4020)
Analyte specific reagents (ASR's) are antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens. ASR's that otherwise fall within this definition are not within the scope of subpart E of this part when they are sold to:
• Automated Cell-Locating Device (FDA Code: JOY / 864.5260)
An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)
• Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays System (FDA Code: NTH / 866.4700)
• Digital Microscopy Systems
• Robotic Microscopy Systems

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