Notice of Intent to Sole Source – Bio-Rad Quality Control Material

Agency: HEALTH AND HUMAN SERVICES, DEPARTMENT OF
State: Maryland
Type of Government: Federal
FSC Category:
  • 65 - Medical, Dental, and Veterinary Equipment and Supplies
NAICS Category:
  • 325414 - Biological Product (except Diagnostic) Manufacturing
Posted Date: May 16, 2025
Due Date: May 27, 2025
Solicitation No: 25-005840
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Description

Follow
Notice of Intent to Sole Source – Bio-Rad Quality Control Material
Active
Contract Opportunity
Notice ID
25-005840
Related Notice
Department/Ind. Agency
HEALTH AND HUMAN SERVICES, DEPARTMENT OF
Sub-tier
NATIONAL INSTITUTES OF HEALTH
Office
NATIONAL INSTITUTES OF HEALTH - CC
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General Information
  • Contract Opportunity Type: Presolicitation (Original)
  • Original Published Date: May 16, 2025 08:22 am EDT
  • Original Response Date: May 27, 2025 06:30 am EDT
  • Inactive Policy: Manual
  • Original Inactive Date: May 28, 2025
  • Initiative:
    • None
Classification
  • Original Set Aside:
  • Product Service Code: 6505 - DRUGS AND BIOLOGICALS
  • NAICS Code:
    • 325414 - Biological Product (except Diagnostic) Manufacturing
  • Place of Performance:
    Bethesda , MD 20892
    USA
Description



Notice of Intent to Sole Source – Bio-Rad Quality Control Material



Product Service Code: 6505

NAICS Code: 325414

Place of Performance:

Bethesda, MD 20892, USA



POTS: 25-005840





This is a Notice of Intent and not a request for quotation. A solicitation document will not be issued, and quotations will not be requested.



The National Institutes of Health (NIH) intends to award an Indefinite Delivery, Indefinite Quantity (IDIQ) contract to Bio-Rad Laboratories Inc., located at 2000 Alfred Nobel Drive, Hercules, CA 94547-1801.



Purpose:



The NIH Department of Laboratory Medicine – Immunoassay Section requires Bio-Rad quality control (QC) materials for use with the Roche COBAS PRO Solutions analyzers. These QC materials are essential to verify the accuracy and reliability of analyzer results.



Bio-Rad QC materials contain known analyte values, enabling validation that instrument outputs are within acceptable limits. This ensures the analyzers function correctly and produce accurate test results. The Immunoassay section specifically requires Bio-Rad materials because they contain the exact analytes at concentrations that match the range of its assays.



Performance Period:



May 28, 2025 – September 30, 2025

Shipments will be made on an as-needed basis.



Items Required:




  1. Bio-Rad InteliQ Tumor Marker Level 1

  2. Bio-Rad InteliQ Tumor Marker Level 2

  3. Bio-Rad InteliQ Tumor Marker Level 3

  4. Bio-Rad InteliQ Immunoassay Plus Level 1

  5. Bio-Rad InteliQ Immunoassay Plus Level 2

  6. Bio-Rad InteliQ Immunoassay Plus Level 3

  7. Bio-Rad InteliQ Specialty Immunoassay Level 1

  8. Bio-Rad InteliQ Specialty Immunoassay Level 2

  9. Bio-Rad InteliQ Specialty Immunoassay Level 3

  10. Bio-Rad Liquichek Cardiac Advance Level 1

  11. Bio-Rad Liquichek Cardiac Advance Level 2

  12. Bio-Rad Liquichek Cardiac Advance Level 3

  13. Bio-Rad Liquichek Cardiac Advance Level 4

  14. Bio-Rad Lyphochek Immunoassay Plus Level 1

  15. Bio-Rad Lyphochek Immunoassay Plus Level 2

  16. Bio-Rad Lyphochek Immunoassay Plus Level 3





Bio-Rad Laboratories Inc. is the sole manufacturer of the required QC materials. No other vendors are known to offer equivalent products that meet the NIH's technical requirements.



This procurement will be conducted under FAR Part 13 – Simplified Acquisition Procedures, specifically Subpart 13.106-1(b)(1), which permits solicitations from a single source when only one source is reasonably available.



Contracts awarded under FAR Part 13 are exempt from the competition requirements outlined in FAR Part 6.





Interested parties who believe they can meet this requirement are invited to submit a capability statement referencing this posting number.



Deadline: May 27, 2024, at 6:30 AM EST

Submit to:

Shasheshe Goolsby, Lead Contract Specialist

Email: shasheshe.goolsby@nih.gov



Please Note: This is NOT a Request for Proposal (RFP). Do not submit quotations or pricing. Only capability statements will be considered.


Attachments/Links
Contact Information
Contracting Office Address
  • 6707 DEMOCRACY BLVD, SUITE 106
  • BETHESDA , MD 20892
  • USA
Primary Point of Contact
Secondary Point of Contact


History
  • May 16, 2025 08:22 am EDTPresolicitation (Original)
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