Opportunity
SAM #75F40126Q00297
FDA Sole Source Procurement: Distek Dissolution System and Autosampler Instrument
Buyer
Food and Drug Administration
Posted
July 10, 2026
Respond By
July 20, 2026
Identifier
75F40126Q00297
NAICS
423490, 334516
The Food and Drug Administration (FDA) is announcing its intent to make a sole source procurement for a dissolution testing system. - Agency: Food and Drug Administration (FDA), Department of Health and Human Services - Procurement Type: Sole source, firm-fixed price order - Product: One (1) Distek Dissolution System and Autosampler Instrument with Accessories - Includes syringe pumps, filters, interchangeable shafts for paddles or baskets - Must provide USB and ethernet connectivity for data retrieval - Must comply with ISO 17025 standards - Delivery and Installation: Required at the Irvine Medical Products Laboratory, Irvine, CA - Delivery Timeline: Within 60 days after contract award - OEM: Distek, Inc. is the only manufacturer specified - No alternative vendors or part numbers are listed - All technical requirements are detailed in the Statement of Work (SOW) attachment - Commercial opportunity is limited to Distek, Inc. due to sole source justification
Description
One (1) Distek Dissolution System and Autosampler Instrument with accessories shall be delivered and installed in Irvine, CA. The required system shall meet all requirements in the attached Statement of Work.