Medical Reagent Manufacturing and Kit Assembly

The contract entails the manufacture and assembly of the Coulter S-Cal Haematology Calibrator Kit, requiring full compliance with FDA regulations, current Good Manufacturing Practices, and ISO 13485 quality management standards. The scope includes formulation of reagents, rigorous quality control procedures, and final packaging to ensure product integrity and regulatory conformity throughout the production lifecycle. All activities must adhere to strict documentation and traceability requirements to meet the stringent demands of clinical diagnostic applications. This subcontract is issued under the NAICS code 325412 for medical and dental instrument manufacturing, with performance expected to align with the standards of the Department of Defense’s Medical Supply Chain division. The solicitation was posted on July 22, 2026, and responses are due by July 28, 2026, with no specific set-aside classifications indicated. The place of performance and point of contact details are not provided, but the work must be executed under the oversight of a federal agency responsible for medical supply readiness, emphasizing reliability and operational readiness in diagnostic reagent supply.