Notice of Intent to issue a Sole Source Award for a GentleMACS Octo Dissociator with Heaters

The Centers for Disease Control and Prevention's National Center for Immunization and Respiratory Diseases intends to issue a sole source award for one GentleMACS Octo Dissociator with heating units and an associated instrument service plan. The procuring agency has determined that Miltenyi Biotec Inc is the only commercially available vendor capable of providing equipment that meets the Government's specialized requirements, including the ability to simultaneously process eight biological samples in a fully closed, sterile system with integrated heating and validated programmable protocols aligned with the Quality Manual for Microbiological Laboratories standards. Key contract requirements include proprietary mechanical dissociation architecture protected by active patents, tissue-specific programs that require no additional programming or modification, support for required consumable formats that maintain sterility and traceability, and proven compatibility with downstream Luminex and single-cell sequencing workflows under current quality and regulatory requirements. The Government will consider all quotations and responses received within 15 days of the notice issuance; however, this notice of intent is not a request for competitive quotations, and the Government retains sole discretion to complete or not complete the proposed purchase order based on responses received. The notice was posted on March 23, 2026, with a due date of April 7, 2026, providing a two-week window for interested parties to submit responses.

This procurement involves no set-aside designations and targets Miltenyi Biotec Inc (UEI # ZLDPMHA3M333), located at 2303 Lindbergh Street, Auburn, California 95602, as the intended sole source awardee. The contract will be structured as a firm fixed price purchase order for a single unit of equipment with service plan coverage. No specific award value or budget range is disclosed in the pre-solicitation notice. The procurement falls under NAICS code 334516 (Analytical Laboratory Instrument Manufacturing) and PSC code 6640 (Laboratory Equipment and Supplies), reflecting the specialized nature of the analytical instrumentation being acquired. The sole source justification centers on the equipment's unique combination of capabilities, proprietary technology, and integration with the Government's validated quality and operational requirements, which no competing system currently duplicates in the marketplace.