Manufacture of Coombs Test Control Reagent

The contract requires the manufacture of a medical reagent control specifically designed for Coombs testing, with production quantities sufficient to support 200 tests per unit. The reagent must meet stringent biological stability standards to ensure consistent performance under expected storage and usage conditions. Strict adherence to cold chain protocols is mandated throughout production, packaging, and shipment to preserve product integrity, reflecting the sensitivity of the biological components involved. All labeling must comply with applicable regulatory requirements, including clear identification, expiration dating, handling instructions, and traceability information to support quality control and regulatory audits. Performance is designated to occur in Hampton, Virginia, with an expected production timeline aligned to the solicitation response deadline of July 20, 2026. The contract is categorized as a subcontract under NAICS code 325412, indicating classification within the pharmaceutical and medicine manufacturing sector. The awarding entity is the Department of Defense through its Medical Supply Chain MD Surg FSF office, underscoring the critical nature of this reagent for clinical and military healthcare applications. While specific point of contact details are not provided, the solicitation is publicly accessible via the DIBBS platform, and qualified vendors must submit proposals prior to the deadline to meet the urgent demand for this validated diagnostic control material.