Manufacturer of FDA-Cleared PCR Test Kits

The contract seeks a manufacturer to produce and authorize the distribution of FDA-cleared in vitro diagnostic PCR test kits targeting multiple infectious agents including MRSA, C. difficile, SARS-CoV-2, Influenza/RSV, Strep A, and MTB/RIF resistance. These kits must meet regulatory standards for clinical use and be labeled as IVD products, ensuring compliance with federal diagnostic testing requirements. The subcontracts are intended to support large-scale diagnostic capacity for use in healthcare settings, with performance expected to occur in Miami, Florida, at the designated zip code 33125-1624. The opportunity is issued under the Department of Veterans Affairs through the 248-NETWORK Contract Office 8 and falls under NAICS code 325412, which pertains to pharmaceutical and medicine manufacturing. As a subcontract, this action does not involve direct government procurement but rather engages qualified manufacturers to supply pre-approved diagnostic tools through an existing contractual framework. Responses are due by August 3, 2026, and interested parties must align with regulatory, logistical, and quality control expectations for high-volume diagnostic kit production and authorized distribution across clinical networks.