The U.S. Food and Drug Administration (FDA) is seeking information from potential sources for the provision of Luminex magnetic carboxylated microsphere beads, or equivalent, for use in fluorescent magnetic immunoassays (FMIA) to support the viral research and review program. The FDA is looking for small business sources that can provide these beads, which must meet specific physical and chemical properties, functional requirements, and quality standards. The beads must have distinct fluorescent signatures, be compatible with multi-laser flow cytometry systems, and have a minimum 6-month shelf life.
• The FDA is seeking capability statements from interested contractors, which should include business information, past performance, descriptive literature, and technical information.
• The capability statements should demonstrate that the respondent is regularly engaged in the sale of same or substantially similar products.
• The FDA reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate.
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