ThunderBolt ELISA Analyzer.

Solicitation Number:75F40124Q00412 This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in FAR 12.6 and FAR 13 as supplemented and additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2024-05, effective 05/22/2024. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is 75F40124Q00412 and is being issued as a Request for Quote (RFQ). The NAICS Code for this solicitation is 334516 and the Small Business Size Standard is 1000 employees. This will be awarded as Firm-Fixed Price and completed as a small business set-aside. Prospective Offerors are responsible for downloading the solicitation and any amendments from SAM.GOV. The Government reserves the right to award an order without discussions if the Contracting Officer determines that the initial offer is providing the Best Value and discussions are not necessary. The U.S. Food and Drug Administration (FDA) requires a ThunderBolt ELISA Analyzer. BACKGROUND AND OVERVIEW Bioanalytical Chemistry requires the purchase of an automated ELISA analyzer to assist in protein -based allergen detection methods. The requested automated ELISA analyzer will provide the necessary requirements that are critical for the quantitation of protein allergens in foods and assist in allergen detection method development and validation. The proposed equipment is required to continue and expand the efforts of the US FDA to protect the US food supply and respond to emergencies in a timely manner. OBJECTIVES/PURPOSE The Office of Regulatory Science, Division of Bioanalytical Chemistry, Chemical Contaminants Branch requires the purchase of an automated ELISA analyzer for high throughput ELISA and Chemiluminescent (CLIA) applications. See attached Combined Synopsis Solictation.75F40124Q00412.