FDA Cell Enumerator

The FDA is seeking information from small businesses capable of supplying a stand-alone bacterial flow cytometer, commonly referred to as a cell enumerator, for use in the Carlson Laboratory at the Center for Biologics Evaluation and Research. This request is issued as a Sources Sought Notice under solicitation number 75F40126SSN134234, which serves as a market survey to assess industry capabilities and is not a formal solicitation or invitation for bids. The device must perform viable bacterial cell enumeration in under five minutes per sample with a two-log linear detection range, be portable or benchtop capable with battery operation, include integrated software for data analysis, and be supplied with consumables for 200 runs. The procurement is restricted to small businesses under NAICS code 334516, with a size standard of 1,000 employees, and all offers must comply with Buy American and Made in America Act requirements, including full disclosure of country of origin and submission of any necessary waivers through the MIAO Digital Waiver Portal. Responses must be submitted via email to timothy.walbert@fda.hhs.gov by July 1, 2026, and must include detailed technical documentation, past performance records from the last three years, business size certification, and Unique Entity ID information, with no reliance on web links or external content. All submissions must be comprehensive and specific, as generic statements will be deemed insufficient. Delivery is required at the U.S. FDA CBER OVRR-DBPAP-LMPCI facility in Silver Spring, Maryland, and no formal contract will be awarded as a result of this notice. The FDA will use the responses gathered to inform the development of a future solicitation, and respondents are advised that neither the government nor the contracting office will reimburse costs incurred in preparing or submitting responses. The office of the primary point of contact is located in Rockville, Maryland, and while technical delivery is directed to Silver Spring, there is no designated Contracting Officer, COR, or COTR identified at this stage. The government retains the right to use any nonproprietary technical information provided in the development of subsequent procurement actions, and respondents are instructed not to include classified, confidential, or sensitive data in their submissions.