Amendment One: Azure 600 Imaging System

Amendment One: The reason for Amendment One is to add the trade in for the existing Azure C600 (Serial Number 60446). All language changes is in Red lettering.

Updated QUOTES DUE: All quotes are due electronically to via email to Patricia.Natividad@fda.hhs.gov no later than August 14, 2024, 10:00 a.m. Eastern Standard Time. All other Terms and Conditions remain the same.

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.and Notice of intent to Sole Source.

The solicitation number for this acquisition is 75F40124Q00416 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 Sole Source to Azure Biosystems. 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 Azure 600 Imaging System. BACKGROUND AND OVERVIEW Imager systems with chemiluminescence for Western blotting are integral tools in the FDA's efforts to protect public health.

These systems provide high sensitivity and specificity in detecting and quantifying proteins, essential for quality control, drug development, medical device evaluation, and safety assessments. By leveraging advanced imaging technology, the FDA ensures that biological products and medical devices are safe, effective, and reliable See Attachment for the Solicitation CDER-2024-122015 07292024, and Solicitation Amendment One CDER-2024-122015