FDA shear flow instrument system

Summary (Newest Update)

Background The U.S. Food and Drug Administration (FDA), specifically the Laboratory of Cellular Hematology (LCH), requires a shear flow instrument system to evaluate human platelets and red blood cells in their physiological environment, aiming to reduce animal usage. The system is designed to mimic in vivo conditions, allowing for easier study of cellular behavior under flow conditions without the complexity of custom-built setups. Work Details The contract involves the procurement of a BioFlux 200+ or equal flexible shear flow system for microscopy. The specifications include: - A stand-alone shear flow system, new and not refurbished; - Compatibility with existing Nikon Eclipse Model TE200-U inverted microscope; - Comprehensive closed system for various cell-related scientific questions; - Uniform and reproducible pressures for cells in microfluidic channels; - Programmable shear flow rates between 0-200 dynes/cm2; - Capable of single and bi-directional flow; - Pulsatile flow simulating heartbeat up to 120/bps; - Environmental control at the sample level with dual gas input options; - Throughput of up to 24 individual experiments per plate; - Configurations for 24, 48, and 96-well plates; - Two shear flow input experiments for gradient-based image analysis from dual inputs; - Inclusion of a computer workstation to run operating software; - Minimum one-year full manufacturer’s warranty. Delivery is required FOB Destination to the FDA Center for Biologics Evaluation and Research (CBER) in Silver Spring, MD. Period of Performance The geographic location(s) the product will be delivered to or performed at. Place of Performance U.S. FDA Center for Biologics Evaluation and Research (CBER), 10903 New Hampshire Avenue, Bldg. 52/72, Room 5320, Silver Spring, MD 20993-0002. Bidder Requirements Bidders must be small business concerns as this solicitation is set aside for them. Offerors must provide an Accessibility Conformance Report (ACR) for compliance with Section 508 accessibility standards.