NAICS Code 325413: In-Vitro Diagnostic Substance Manufacturing

National industry

SBA small business size standard: 1,250 employees

Definition

This U.S. industry comprises establishments primarily engaged in manufacturing in-vitro (i.e., not taken internally) diagnostic substances, such as chemical, biological, or radioactive substances. The substances are used for diagnostic tests that are performed in test tubes, petri dishes, machines, and other diagnostic test-type devices.

Code facts

Contract awards
990 In the last 12 months
Contract obligations
$175,464,471 In FY2025

NAICS codes and definitions come from the U.S. Census Bureau, size standards from the SBA and contract spending from SAM.gov/FPDS.

Business activities under NAICS 325413

  • Blood derivative in-vitro diagnostic substances manufacturing
  • Blood glucose test kits manufacturing
  • Coagulation in-vitro diagnostic substances manufacturing
  • Cytology and histology in-vitro diagnostic substances manufacturing
  • Diagnostic substances, in-vitro, manufacturing
  • Enzyme and isoenzyme in-vitro diagnostic substances manufacturing
  • Hematology in-vitro diagnostic substances manufacturing
  • HIV test kits manufacturing
  • Hormone in-vitro diagnostic substances manufacturing
  • In-vitro diagnostic substances manufacturing
  • Microbiology, virology, and serology in-vitro diagnostic substances manufacturing
  • Pregnancy test kits manufacturing
  • Viral in-vitro diagnostic test substances manufacturing

Contract obligations by fiscal year

Fiscal year Obligated
FY2027 To date $15,057,124
FY2026 $165,900,412
FY2025 $175,464,471
FY2024 $150,442,619
FY2023 $1,954,570,224

Top contractors by obligations

Rank Contractor Obligated, FY2026–FY2027 Share
1 Cepheid $34,569,687
2 Biomerieux Inc. $29,939,529
3 Roche Diagnostics Corporation $22,320,868
4 Quest Diagnostics Incorporated $8,859,959
5 Hologic Sales And Service, LLC $4,622,310
6 Fisher Scientific Company L.L.C. $4,492,677
7 Abbott Laboratories Inc. $4,462,958
8 Werfen USA LLC $4,390,715
9 Beckman Coulter, Inc. $4,093,582
10 Vmrd Inc. $3,330,499

Top funding agencies by obligations

Rank Agency Obligated, FY2026–FY2027 Share
1 Department of Veterans Affairs $114,667,828
2 Defense Health Agency Department of Defense $47,988,500
3 Department of Health and Human Services $9,838,345
4 Department of Agriculture $4,780,295
5 Department of the Navy Department of Defense $1,427,068
6 Defense Logistics Agency Department of Defense $1,119,338
7 Air Force Department of Defense $913,410
8 Department of the Army Department of Defense $872,002
9 Department of State $447,787
10 Department of Justice $155,183

Contract obligations by state

Rank Place of performance Obligated, last 12 months Share
1 California $31,611,524
2 Utah $15,396,605
3 Texas $13,181,566
4 Indiana $9,171,310
5 Maryland $6,776,536
6 New Jersey $5,940,640
7 Georgia $5,796,914
8 Washington $5,360,033
9 Arizona $5,315,090
10 Massachusetts $4,736,339
11 Iowa $3,942,221
12 Ohio $3,569,885
13 Illinois $2,967,811
14 North Carolina $1,387,619
15 New York $1,314,196
16 Pennsylvania $1,281,346
17 Michigan $1,187,353
18 Connecticut $1,165,284
19 Minnesota $875,070
20 Colorado $819,065
21 South Carolina $774,680
22 Missouri $619,409
23 Kentucky $591,333
24 Wisconsin $553,148
25 Mississippi $440,321
26 Florida $422,391
27 Kansas $350,196
28 Guam $344,181
29 District of Columbia $202,580
30 Oregon $152,538
31 Nevada $124,926
32 Nebraska $111,161
33 Delaware $106,954
34 North Dakota $103,173
35 Alabama $91,219
36 Hawaii $85,934
37 Arkansas $73,320
38 Puerto Rico $62,258
39 Montana $56,564
40 New Mexico $42,977
41 Alaska $36,148
42 Idaho $33,790
43 Oklahoma $9,681
44 Maine $8,831
45 South Dakota $7,504
Show all 45

Shares are of everything obligated under NAICS 325413 in the last 12 months before deobligations, including work performed abroad or with no place of performance on record.

Contract opportunities

Notice Posted Due
6550--Micro Reagents and Service Contract Award Notice · Veterans Integrated Service Network 17 (VHA) —
NTX Kits, Reagents, and Supplies Award Notice · Veterans Integrated Service Network 17 (VHA) —
NTX Blood Bank Cost Per Test Award Notice · Veterans Integrated Service Network 17 (VHA) —
6550--Analyzer Preventive Maintenance and Service Pre-Solicitation · Veterans Integrated Service Network 22 (VHA)
6550--Alba Bioscience Inc. (PENDING PROPOSAL) Award Notice · Veterans Integrated Service Network 12 (VHA) —
Flow Cytometry Reagents Pre-Solicitation · Veterans Integrated Service Network 5 (VHA)
6550-- Roche Ventana Reagents IDIQ 5 Successive 1 Year Delivery Orders Solicitation · Veterans Integrated Service Network 16 (VHA)
6550--Abbott Architect i1000 Reagents and Consumables Solicitation · Veterans Integrated Service Network 22 (VHA)
Reagents and consumables for Roche immunostainers Solicitation · Office of Logisitics and Acquisition Operations (NIH) · 75N98027Q00026
6550--Blood Type IVD Reagents Solicitation · Veterans Integrated Service Network 22 (VHA)
6505--dressing, drawtex 4IN X 4IN (VA-27-00014447) Pre-Solicitation · Veterans Integrated Service Network 15 (VHA)
6550--Blood Bank Reagents Pre-Solicitation · Veterans Integrated Service Network 17 (VHA)
6550--Optilite analyzer reagents Solicitation · Veterans Integrated Service Network 22 (VHA)
6550--VISN Cepheid GeneXpert Testing Supplies Base Plus 3 Op Yr RFQ Solicitation · Veterans Integrated Service Network 5 (VHA)
Reagents and consumables for Roche immunostainers Pre-Solicitation · Office of Logisitics and Acquisition Operations (NIH) · PCA-NCI-04352
NOI - DNA Sequencing of Bone Marrow Failure Syndro Solicitation · Office of Logisitics and Acquisition Operations (NIH)
6550 Microbiology Testing Media for MRSA and VRE, purchase order for Microbiology Media Special Notice · Veterans Integrated Service Network 20 (VHA) · 36C26027Q0096_0001
Cost Per Reportable Result Purchase of Immunohistochemistry Reagents for Laboratory Tests. Pre-Solicitation · Veterans Integrated Service Network 20 (VHA)
BPA - Consumable Supplies for Terumo Trima Accel Blood Collection systems Solicitation · Defense Health Agency
6550--hemochron signature elite reagents and supplies Pre-Solicitation · Veterans Integrated Service Network 22 (VHA)
Q301--VA Boise, Idaho - Blood Bank Reagents Requirement Pre-Solicitation · Veterans Integrated Service Network 20 (VHA)
6515--CATH, EXTERNAL EXTENDED WEAR MED - 762-27-1-040-0001 - Tucson 762 Pre-Solicitation · Veterans Integrated Service Network 15 (VHA)
6550 Microbiology Testing Media for MRSA and VRE, purchase order for Microbiology Media Solicitation · Veterans Integrated Service Network 20 (VHA) · 36C26027Q0069
6550--Abbott Architect i1000 Reagents Pre-Solicitation · Veterans Integrated Service Network 22 (VHA)
BioMerieux rapid microbial identification (ID) and antibiotic susceptibility testing Special Notice · Defense Health Agency
6640--echo lumena- werfen Award Notice · Veterans Integrated Service Network 6 (VHA) · 36C24627R0005 —
6640--echo lumena- werfen Award Notice · Veterans Integrated Service Network 6 (VHA) · 36C24627Q0050 —
6550--lab - abbott alinity-M PCR molecular reagents & supplies Award Notice · Veterans Integrated Service Network 2 (VHA) —
6550--Roche Ventana Reagents - Source Sought Notice New Orleans VAMC Pre-Solicitation · Veterans Integrated Service Network 16 (VHA)
DO Biofire Panel Kits Solicitation · Veterans Integrated Service Network 23 (VHA)
6640--618-27-1-106-0024 - Supply - DO Biofire Panel Kits - MPLS 36F79724D0020 - 36C26326N0061 Limited / Sole Source Justification · Veterans Integrated Service Network 23 (VHA) —
6550--Werfen Immunocor Blood Bank Reagents and Supplies Northport and East Orange Award Notice · Veterans Integrated Service Network 2 (VHA) —
6550--VISN 19 Lab BioFire Reagents & Maintenance on Biofire TORCH systems Intent to Sole Source Limited / Sole Source Justification · Veterans Integrated Service Network 19 (VHA) —
Purchase of Rapid Syndromic Molecular Testing Reagents for Seattle VAMC Award Notice · Veterans Integrated Service Network 20 (VHA) —
Validity and Drug of Abuse Reagent Award Notice · Veterans Integrated Service Network 23 (VHA) —
6550--Blood Gas Analyzer Reagents, Controls, and Supplies IDIQ Award Notice · Veterans Integrated Service Network 21 (VHA) —
Redacted Justification and Approval for Other Than Full and Open Competition Sequencing System for HIV-1 Genotype Testing Limited / Sole Source Justification · Defense Health Agency —
6640--Abbott - Alinity M Reagents - IC Award Notice · Veterans Integrated Service Network 23 (VHA) —
6550--DO Biofire Panel Kits in support of the Sioux Falls VA HCS Award Notice · Veterans Integrated Service Network 23 (VHA) —
6640--BRAND NAME OR EQUAL Flow Cytometry Reagents - MPLS Award Notice · Veterans Integrated Service Network 23 (VHA) —
Defense Logistics Agency - Troop Support – Europe & Africa Indefinite Delivery/Indefinite Quantity (IDIQ) Contract for Laboratory Reagents, Test Kits, and Consumables Pre-Solicitation · Medical Supply Chain (DLA)
Show 31 more

Latest 41 of 10,314 listed here. See the rest on GovTribe.

Size standard history

Federal Register rules that named this code

From the NAICS codes each rule's amendments to 13 CFR 121.201 name. Rules that print their size standard tables as images aren't listed.

Quick answers

What is NAICS 325413?

NAICS 325413 is In-Vitro Diagnostic Substance Manufacturing, a national industry in NAICS 31-33, Manufacturing.

What is the NAICS code for HIV test kits manufacturing?

The NAICS code for HIV test kits manufacturing is 325413, In-Vitro Diagnostic Substance Manufacturing.

What is the NAICS code for pregnancy test kits manufacturing?

The NAICS code for pregnancy test kits manufacturing is 325413, In-Vitro Diagnostic Substance Manufacturing.

What is the NAICS code for blood glucose test kits manufacturing?

The NAICS code for blood glucose test kits manufacturing is 325413, In-Vitro Diagnostic Substance Manufacturing.

When did the size standard for NAICS 325413 last change?

The most recent Federal Register rule on record that names NAICS 325413 in the SBA's size standards is "Small Business Size Standards for Manufacturing" (81 FR 4469), published Jan 26, 2016 and effective Feb 26, 2016.

How much do federal agencies spend under NAICS 325413?

Federal contracts under NAICS 325413 obligated $175,464,471 in fiscal year 2025 and $2,461,434,849 in fiscal years 2023 through 2027.

Who are the largest contractors under NAICS 325413?

The contractors with the most obligated under NAICS 325413 in fiscal years 2026 and 2027 are Cepheid ($34,569,687), Biomerieux Inc. ($29,939,529) and Roche Diagnostics Corporation ($22,320,868).

Which agencies buy the most under NAICS 325413?

The agencies that obligated the most under NAICS 325413 in fiscal years 2026 and 2027 are Department of Veterans Affairs ($114,667,828), Defense Health Agency ($47,988,500) and Department of Health and Human Services ($9,838,345).

Which PSC codes are used with NAICS 325413?

The PSC codes with the most obligated under NAICS 325413 in fiscal years 2026 and 2027 are 6550 In Vitro Diagnostic Substances, Reagents, Test Kits and Sets; 6640 Laboratory Equipment and Supplies; and Q301 Reference Laboratory Testing.

Where is the work under NAICS 325413 performed?

By place of performance, the states with the most contract obligations under NAICS 325413 over the last 12 months are California ($31,611,524), Utah ($15,396,605) and Texas ($13,181,566).

What is the latest contract opportunity under NAICS 325413?

The latest contract opportunity under NAICS 325413 is 6550--Micro Reagents and Service Contract, award notice from Veterans Integrated Service Network 17 (VHA), posted November 6, 2026.

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See everything under NAICS 325413

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