Maintenance of IncuCyte System

NOTICE OF INTENT TO SOLE SOURCE In support of Project No: CDRH-2023-117798 The Food and Drug Administration, Office of Acquisitions and Grant Services, Facility Support Branch intends to award a firm fixed price purchase order to Sartorius Corporation (Sartorius), Bohemia, New York 11716-2606 for a 12-month maintenance service agreement with four 12 month Option periods in support of one (1) Live Cell Analysis System (IncuCyte S3 Live-Cell Analysis System) for the Center for Devices and Radiological Health (CDRH). Sartorius is the manufacture and only source able to provide maintenance for the IncuCyte S3 Live-Cell Analysis System. Any material or service must be compatible in all aspects (form, fit, and function) with the existing systems currently installed, and be able connect or interface with other pre-existing systems. Only Sartorius, the original equipment manufacturer (OEM) of the IncuCyte S3, can provide the support services because the equipment is proprietary to this company. As the OEM authorized service provider, Sartorius is the only source with direct access to OEM parts, propriety software, as well as certified and trained technicians able to provide the services for the IncuCyte S3 Live-Cell Analysis System. Sartorius does not offer any parts or services to third party vendors, and Sartorius does not authorize any other vendors to perform services for their equipment. This procurement is being conducted in accordance with FAR subpart 13.106-1(b)(1)(i) which allows the Contracting Officer to solicit from one source. The North American Classification System Code is 811210, Other Electronic and Precision Equipment Repair and Maintenance and Product Service Code, J066 – Maintenance/Repair/Rebuild of Equipment – Instruments and Laboratory Equipment. This notice is being distributed solely via the General Services Administration’s System for Awards Management website (www.SAM.gov). As Sartorius is the only source that can meet the Government’s need at this time, this notice is not a request for competitive quotes. However, if any interested parties, especially a small business believes it can meet the Government’s needs, it may identify their interests and/or capability in relation to this procurement to the Lead Contract Specialist, Sheneil Green, at [email protected] no later than 10:00 AM EST on September 7, 2023 . Responses sent utilizing other means will not be considered. Information received will be used solely to determine whether to conduct a competitive procurement. A determination by the Government not to compete the proposed action based upon responses to this notice is at the discretion of the Government. All responses must include the following business information: Unique Entity Identification (UEI) Number Company Name, address, primary point of contact and their email and phone number Type of company (i.e., small business, 8a, woman owned, HubZone, veteran owned, etc.) as validated in SAM.gov. All interested parties must be registered in SAM.gov to receive consideration of government contracts.