Medical Diagnostic Test Kit Manufacturing and Packaging

The contract pertains to the manufacture and packaging of qualitative hCG pregnancy test kits designed to meet stringent diagnostic standards, including specific sensitivity thresholds, minimum shelf-life requirements, and full compliance with labeling regulations. All components must be sourced, assembled, and packaged to ensure consistent performance and regulatory adherence, with strict quality control protocols applied throughout production. The work is to be performed at Fort Bragg, North Carolina, under a subcontract arrangement within the Department of Defense’s Medical Supply Chain network, and all deliverables must align with the technical specifications and compliance expectations set forth by the contracting entity. Bids must be submitted by August 3, 2026, and the NAICS code 325414 indicates this falls under the medical and dental instrument manufacturing sector. The contract is part of a broader effort to ensure reliable, on-demand diagnostic capacity for military and related healthcare operations. While no set-aside status is specified, the project requires full adherence to federal procurement standards for medical devices, including documentation of batch traceability, environmental controls during packaging, and validation testing to confirm accuracy and uniformity across production runs. The kits will be deployed in field medical settings, necessitating durability, clear labeling, and compatibility with existing clinical workflows.