About This SBOM

A Software Bill of Materials (SBOM) is a formal, machine-readable inventory of the commercial, open-source, and off-the-shelf software components contained in a product. Co-Dx makes SBOMs available for the PCR Pro Mobile Application and Instrument Firmware to support customer and regulatory cybersecurity risk management, consistent with the transparency expectations of Section 524B of the FD&C Act and FDA guidance on cybersecurity in medical devices.

Products Covered

• PCR Pro Application
• Instrument Firmware

What the SBOM Includes

• Component name, supplier, and version
• Unique identifiers and dependency relationships
• Level of support and end-of-support status for each component
• Known vulnerability status for listed components, where available
• Delivery in an industry-standard, machine-readable format (e.g., SPDX or CycloneDX)

Why Access Is Controlled

To protect patients, customers, and devices in the field, Co-Dx does not publish SBOMs publicly. SBOMs are shared on request with verified users.

Each request is reviewed, and approved SBOMs are delivered securely to the verified requester. SBOMs are provided for the requester’s internal cybersecurity risk management and may not be redistributed without written permission from Co-Dx.

Reporting a Security Concern

If you believe you have identified a potential vulnerability in a Co-Dx product, please describe it in the request form below and our team will follow up.