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Bionostics Holdings

Devens, Massachusetts, United States

Ownership: Private
Development stage: Other

Overview

Bionostics developed and manufactured FDA-cleared, proprietary calibrators and quality control products mainly for OEM in vitro diagnostic (IVD) systems, especially for point-of-care use in devices for blood glucose, blood gas, and increasingly for coagulation, cholesterol, and HbA1c. Its products are integrated components of OEMs' FDA 510(k) submissions, making them essential to the performance and approval of commercial diagnostic systems[1][2][7].

Therapeutic areas: HematologyEndocrinologyOtherCardiovascular
Modalities: DeviceQuality control solution
Industry: Consumable Medical Devices

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OEM relationships with major global IVD manufacturers

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