FDA Cell Enumerator

The FDA Office of Acquisition and Grant Services intends to solicit a cell enumerator (bacterial flow cytometer) for the Carlson Laboratory at the Center for Biologics and Review, with capability statements due by July 1, 2026. The requirement is set aside for small business under NAICS 334516 (Analytical Laboratory Instrument Manufacturing).

The cell enumerator must be a stand-alone, portable or benchtop bacterial flow cytometer capable of rapid assessment in less than five minutes per sample, with a 2-log linear range and ability to enumerate viable/intact bacterial cells. The unit must include software for data visualization and analysis, dilution dispenser, flow cells, and consumables for 200 runs. The laboratory will use the equipment to assess and develop assays measuring potency of Live Biotherapeutic Products and Fecal Microbiota Transplantation products, and to evaluate the BactoBox counter's capability compared to traditional plating and live-dead staining methods, particularly in response to IND submissions.

Delivery location is the FDA facility in Silver Spring, Maryland. This is a sources-sought notice; responses are not binding on the government, though a formal synopsis or combined synopsis/solicitation may be published on SAM.gov following review. Capability statements should reference number 75F40126SSN1334234 and be submitted to timothy.walbert@fda.hhs.gov by 2:00 p.m. Central Time on July 1, 2026. Responses must include company information, SAM/UEI number, business size status, past performance within the last three years, technical specifications, service initiation capability, relevant contract vehicles, warranty and payment terms, country of origin, and informational pricing.