Medical Laboratories

NAICS 621511 obligated $460 million in FY2025 with VA first at $279 million. CLIA certification, not size or price, is what qualifies a laboratory to compete.

NAICS 621511 · Sector 62: Health Care and Social Assistance · Published

By Outrider Editorial Team

SBA size standard

$41.5 million

Measured by average annual receipts over the last 5 fiscal years

SBA table effective March 2023

Official definition

This U.S. industry comprises establishments known as medical laboratories primarily engaged in providing analytic or diagnostic services, including body fluid analysis, generally to the medical profession or to the patient on referral from a health practitioner.
U.S. Census Bureau, NAICS 2022

FY2025 federal spending

The Department of Veterans Affairs bought 61% of the $460.1M obligated under 621511 in FY2025.

Contract awards
2,753
Contract vehicles (IDVs)
410

Top buying agencies

  1. Department of Veterans Affairs$279.2M
  2. Department of Defense$126.9M
  3. Department of Health and Human Services$35.0M
  4. Department of Justice$12.5M
  5. Agency for International Development$9.5M

FY2025 federal contract obligations, USAspending.gov

NAICS 621511 obligated $460 million in FY2025 across 2,753 contract awards. VA leads at $279 million for reference and specialty testing that its own laboratories do not perform, DoD follows at $127 million, HHS at $35 million, DOJ at $13 million for correctional and forensic health testing, and USAID at $9 million for overseas program testing.

What belongs here

Establishments known as medical laboratories providing analytic or diagnostic services, including body fluid analysis, to the medical profession or to patients on referral from a health practitioner.

  • Physical and chemical testing that is not medical or veterinary is 541380.
  • Manufacturing the analyzers and instruments is 334516.
  • Ambulatory health services that are not laboratory work are 621999.

Competing in this code

410 IDVs against 2,753 awards at an average around $167,000 describes recurring reference testing agreements, not one-time buys. Qualification is regulatory: CLIA certification at the complexity level of the tests performed, College of American Pathologists accreditation where the requirement calls for it, and state licensure for the jurisdictions where specimens originate. Federal buyers treat those as pass or fail. The commercial differentiator that actually moves awards is turnaround time and results interface capability, because a laboratory that can deliver structured results into the agency's health record system removes a real operational burden.

NAICS 621511 FAQ

What is the SBA size standard for NAICS 621511?

SBA sets it at $41.5 million in average annual receipts, averaged over your last five completed fiscal years. Come in at or under that and you are small on every NAICS 621511 solicitation, including the set-asides.

Which agencies buy laboratory testing under NAICS 621511?

FY2025 obligations: VA ($279 million), DoD ($127 million), HHS ($35 million), DOJ ($13 million), USAID ($9 million). VA's share is reference and specialty testing sent out from its own laboratories, and DOJ's is correctional and forensic health testing.

What qualifies a laboratory to compete under NAICS 621511?

CLIA certification at the complexity level of the tests being performed, accreditation such as College of American Pathologists where the solicitation requires it, and state licensure covering the jurisdictions where specimens originate. Federal buyers treat these as pass or fail requirements, not evaluation factors.

What actually differentiates competing laboratories on federal awards?

Turnaround time and results delivery. A laboratory that can push structured results directly into the agency's health record system removes an operational burden that agencies feel every day. With 410 IDVs supporting 2,753 awards, these are recurring reference testing relationships where daily workflow friction matters more than unit price.

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