Notice of Intent to Sole Source Reagents, calibrators and controls to be used in conjunction with the VITROS 3600 Immunodiagnostic system, manufactured by QuidelOrtho Sales Company, LLC
Closed Pre-Solicitation Posted
- Solicitation number
- 99090
- Agency
-
CDC Office of Acquisition Services
Centers for Disease Control and Prevention, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 325413 In-Vitro Diagnostic Substance Manufacturing
- Place of performance
- Atlanta, Georgia, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The Centers for Disease Control and Prevention intends to sole-source reagents, calibrators, and controls for the VITROS 3600 Immunodiagnostic system to QuidelOrtho Sales Company, LLC, with an expression of interest deadline of July 31, 2026. This procurement action is conducted under FAR 13.106-1(b) based on exclusive licensing agreements and proprietary data, with no competitive procurement anticipated unless the government determines to proceed following review of capability statements.
Place of performance is not specified, though the requirement supports a hepatitis B and C serosurvey of 5,000 specimens from Mozambique. The CDC Laboratory Branch's Division of Viral Hepatitis uses the FDA-approved VITROS 3600 system exclusively for its hepatitis antibody surveillance program. Required items include hepatitis B core antibody, hepatitis B surface antigen, hepatitis B confirmatory kit, hepatitis B e antigen, anti-hepatitis C antibody, matching complementary controls, calibrators, diluent, check solutions, wash buffer, signal reagents, and consumables. The system provides advantages including reduced testing time, low-volume multi-marker capability, single-vendor procurement streamlining, and automatic data integration with the Enterprise Laboratory Information Management System with quality control processing. A search found no alternative sources to the VITROS 3600 system.
The estimated procurement amount is $97,229.54. Interested parties must submit expressions of interest with detailed capability data, pricing, and technical information demonstrating comparable capability to qty0@cdc.gov by 5:00 PM ET on July 31, 2026. NAICS 325413 (In-Vitro Diagnostic Substance Manufacturing); PSC 6550 (In Vitro Diagnostic Substances, Reagents, Test Kits and Sets).
Notice text
NOTICE OF INTENT TO AWARD A SOLE SOURCE ACTION to QuidelOrtho Sales Company, LLC (UEI: ZFXRG96JMJ39), 9975 Summers Ridge Road, San Diego, CA 92121-2997, for the acquisition of: Reagents, calibrators and controls to be used in conjunction with the VITROS 3600 Immunodiagnostic system.
This procurement action is being conducted under the authority of FAR 13.106-1(b), Soliciting from a Single Source, in accordance with Federal Acquisition Regulation (FAR) Subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, in conjunction with the policies and procedures for solicitation, evaluation, and award as prescribed in FAR 13, Simplified Acquisition Procedures. The North American Industry Classification System (NAICS) code is 325413 and the associated Product Service Code (PSC) is 6550.
This Notice of Intent is not a request for Proposals or Quotations. No solicitation document exists, and no telephone or email inquiries will be accepted. No contract award will be made based on proposals, or quotations received in response to this notice. Interested persons may identify their interest and capability to respond to the requirement and should furnish detailed data concerning their capabilities to provide services sought including pricing data and technical data sufficient to determine that a comparable source to the government is available. The government may consider all “Expression of Interest” documentation received no later than 5:00 PM ET, 31-JUL-2026. A determination by the government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered for the sole purpose of determining whether to conduct a competitive procurement. Responses to this notice must be emailed to qty0@cdc.gov. Submitters are responsible for ensuring their email reaches the designated contracting officer on-time.
Files
| File | Type | Posted |
|---|---|---|
| A4 SSJ_sam.gov.pdf |
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