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Analytical & Clinical Validation Laboratory Services

Active

Federal

Response Deadline12/04/2026, 05:00:00 PM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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This subcontract for Analytical and Clinical Validation Laboratory Services supports prime contractors on diagnostic device projects for the NIH/NIBIB. The scope of work involves performing technical and analytical validation studies, specifically focusing on diagnostic testing protocols such as clinical sensitivity, specificity, cross-reactivity, and Limit of Detection. All work must be conducted in accordance with FDA regulatory guidance for the diagnostic industry, with final deliverables consisting of templated validation reports. To execute these services, the provider must have access to laboratory equipment and facilities rated at BioSafety Level 2 or higher. This opportunity is categorized under NAICS code 541380 and is associated with the Department of Health and Human Services. Interested parties must submit their responses by December 4, 2026.

General Info

Subcontract for NIH diagnostic validation services requiring BSL-2 facilities, due December 4, 2026.

Agency

Department Of Health And Human Services → National Institutes Of Health Olao

NAICS

541380 - Testing Laboratories and Services

Place of Performance

MD

Set-Aside

NONE

Documents

This scope was carved out of 75N98027R00015.

The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

R--National Institute of Biomedical Imaging and Bioengineering (NIBIB) Innovation

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Timeline

PostedNov 3

subcontract

Response DeadlineDec 4

Submission deadline

Response Deadline

12/04/2026, 05:00:00 PM UTCin about 1 month

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health Olao

ContactsNo contacts available

OfficeN/A

Organization / AgencyDepartment Of Health And Human Services → National Institutes Of Health Olao

Office AddressN/A

ContactsNo contact information available

Full Description

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Performs technical and analytical validation studies for prime contractors on NIH/NIBIB diagnostic device projects. Conducts diagnostic testing protocols including Limit of Detection (LOD), cross-reactivity, clinical sensitivity, and specificity testing. Requires BioSafety Level 2 (BSL-2) or greater facilities and laboratory equipment. Adheres to FDA regulatory guidance for the diagnostic industry. Delivers templated validation reports.

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