Description
The U.S. Food and Drug Administration (FDA) is seeking a cell enumerator for the assessment and development of assays to measure the potency of Live Biotherapeutic Products (LBPs) and Fecal Microbiota Transplantation (FMT) products. The cell enumerator should be a stand-alone bacterial flow cytometer that can count live organisms in samples and be customizable in configuration. It should also have a 2-log linear range, be portable, and include software for data visualization and analysis. The FDA is looking for companies that can provide the equipment and/or services described in the notice.
* The cell enumerator should be a stand-alone bacterial flow cytometer for counting live organisms in samples and be customizable in configuration.
* The cell enumerator should be capable of rapid sample assessment (less than 5 minutes per sample).
* The cell enumerator should have a 2-log linear range to allow assessment of varied sample concentrations.
* The cell enumerator should have the ability to enumerate (count) viable/intact bacterial cells.
* The cell enumerator should be a portable/benchtop design.
* The cell enumerator should include software for data visualization and analysis.
* The cell enumerator should include all peripherals and related items required for sample processing and running.
* The cell enumerator should include a dilution dispenser.
* The cell enumerator should include flow cells.
* The cell enumerator should include all required consumables for 200 runs.