Thermo Scientific Auto Trace 280 Solid Phase Extraction (SPE) System or Equivalent

Agency: HEALTH AND HUMAN SERVICES, DEPARTMENT OF
State: Federal
Type of Government: Federal
FSC Category:
  • 66 - Instruments and Laboratory Equipment
NAICS Category:
  • 334516 - Analytical Laboratory Instrument Manufacturing
Set Aside: SBA Certified Women-Owned Small Business (WOSB) Program Set-Aside (FAR 19.15)
Posted Date: Aug 29, 2025
Due Date: Sep 4, 2025
Solicitation No: 75F40125Q00404
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Description

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Thermo Scientific Auto Trace 280 Solid Phase Extraction (SPE) System or Equivalent
Active
Contract Opportunity
Notice ID
75F40125Q00404
Related Notice
Department/Ind. Agency
HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier
FOOD AND DRUG ADMINISTRATION
Office
FDA OFFICE OF ACQ GRANT SVCS
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General Information
  • Contract Opportunity Type: Combined Synopsis/Solicitation (Original)
  • Original Published Date: Aug 29, 2025 03:11 pm EDT
  • Original Date Offers Due: Sep 04, 2025 01:00 pm EDT
  • Inactive Policy: 15 days after date offers due
  • Original Inactive Date: Sep 19, 2025
  • Initiative:
    • None
Classification
  • Original Set Aside: SBA Certified Women-Owned Small Business (WOSB) Program Set-Aside (FAR 19.15)
  • Product Service Code: 6640 - LABORATORY EQUIPMENT AND SUPPLIES
  • NAICS Code:
    • 334516 - Analytical Laboratory Instrument Manufacturing
  • Place of Performance:
Description

The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality Research – St. Louis (OPQR–St. Louis), requires the acquisition of a Thermo Scientific AutoTrace 280 Solid Phase Extraction (SPE) System or equivalent, including delivery, installation, qualification (IQ/OQ), training, and warranty. The system will support the FDA’s nitrosamine testing program by automating pre-concentration of contaminants such as NDBA, NDMA, NMOR, and NDEA from large-volume intravenous (IV) drug products to ensure reproducible and accurate results.



Interested vendors are advised to carefully read the attached Combined Synopsis/Solicitation (CSS 75F40125Q00404) in its entirety for full details, submission instructions, and applicable provisions/clauses.



Questions are due no later than September 2, 2025, at 10:30 AM Eastern Time (ET).

Quotations are due no later than September 4, 2025, at 4:00 PM Eastern Time (ET).


Attachments/Links
Contact Information
Contracting Office Address
  • 4041 Powder Mill Road 4th Floor
  • Beltsville , MD 20705
  • USA
Primary Point of Contact
Secondary Point of Contact


History
  • Aug 29, 2025 03:11 pm EDTCombined Synopsis/Solicitation (Original)
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