IVD point-of-care diagnostic test for SARS-CoV-2 detection using LAMP-based nucleic acid amplification technology. TGA ARTG-listed for human health applications with no cold chain requirement.
Manufactured by
Australia
ZiP Diagnostics is a point-of-care diagnostic manufacturer developing and manufacturing high-sensitivity, low-cost diagnostics that improve health outcomes and healthcare efficiency at the point of need. ZiP's two proprietary platforms—ZiP-ARRAY, a multiplexed lateral flow array platform, and ZiP-P2, a rapid multiplexed molecular diagnostic platform—are designed for field-deployable, near-patient use. ZiP's diagnostic portfolio spans human health, animal health, and environmental monitoring applications, with a growing range of tests across infectious disease, biosecurity, and water quality. ZiP offers contract development and manufacturing services to diagnostic developers, reagent manufacturers, and life science partners seeking an integrated pathway from concept to market-ready product. Contract services are available across five areas: multiplexed lateral flow array development and manufacture covering the full pathway from target panel concept to cartridge-ready product; rapid molecular assay development and manufacture encompassing assay design, optimization, and scale-up; precision lyophilization services supporting stabilization of assay reagents, antibody conjugates, and recombinant proteins in both cake and high-precision bead formats; lyophilized biological control materials for quality assurance; and recombinant protein production delivering functionally validated proteins at scale, optimized for lateral flow and molecular diagnostic applications. All services are delivered under an ISO13485 certified quality management system, with production carried out in ISO7 cleanroom suites, supporting regulatory requirements across multiple markets.
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