Notice of Intent to Sole Source Reagents, calibrators and controls to be used in conjunction with the VITROS 3600 Immunodiagnostic system, manufactured by QuidelOrtho Sales Company, LLC

The Centers for Disease Control and Prevention is prepared to award a sole source contract to QuidelOrtho Sales Company, LLC for the procurement of reagents, calibrators, controls, diluent, wash buffer, signal reagents, and consumables specifically designed for use with the VITROS 3600 Immunodiagnostic System. This procurement is justified under FAR 13.106-1(b) and FAR 8.405-6 due to the proprietary nature of the products, their exclusive compatibility with the FDA-approved VITROS 3600 platform, and the absence of any viable alternative sources that meet the technical and regulatory requirements necessary for accurate clinical testing. The supplies are critical to supporting a 5,000-specimen hepatitis B and C serosurveillance program in Mozambique and must integrate seamlessly with the existing ELIMS laboratory information system to ensure data integrity and operational continuity. The NAICS code is 325413 and the PSC is 6550, with the place of performance designated at the CDC’s facility in Atlanta, Georgia. The solicitation number is 99090 and the procurement request number is 000HCKED-2026-99090. This action is not a formal solicitation for competitive bids but a Notice of Intent to Sole Source, where interested parties may submit an Expression of Interest with detailed technical and pricing data no later than 5:00 PM ET on July 31, 2026, to qty0@cdc.gov. The government will use any submissions solely to assess whether a competitive procurement is feasible, and the decision to proceed without competition is at its sole discretion. No formal evaluation factors, scoring criteria, or trade-off methodology will be applied; award is based entirely on statutory justification. The Unique Entity ID for the contractor is ZFXRG96JMJ39, and while the contract type is inferred as Firm-Fixed-Price due to the nature of the items, this is not explicitly confirmed. No pricing, quantities, or contract value are disclosed in the documentation, and no packaging, preservation, labeling, or invoicing specifications are detailed. Payment will be handled by the CDC Office of Financial Resources in Atlanta, Georgia, and the contracting officer’s point of contact is listed as Brian Swann, though the Contracting Officer field remains incomplete. The requirement is urgent and time-sensitive to support ongoing global health operations, and