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NAICS Code· 325413

NAICS 325413: In-Vitro Diagnostic Substance Manufacturing

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. Cross-References.Show more

NAICS 325413 – In-Vitro Diagnostic Substance Manufacturing encompasses the production of reagents, kits, calibrators, controls, and other chemical or biological substances used in laboratory-based diagnostic testing. These products enable the detection, measurement, or monitoring of physiological conditions, infectious agents, biomarkers, and genetic markers in clinical specimens such as blood, urine, and tissue.

51
Active Contracts
$193.7M
Total Obligations (12mo)
1.2K
Awarded Contracts (12mo)
174
Contractors Awarded (12mo)
1
Median Bidders per Award
-75.3%
YoY Growth

Industry Spending Overview

Federal obligations, top contractors and agencies, and related industry codes for NAICS 325413.

AI Industry Description

NAICS 325413 – In-Vitro Diagnostic Substance Manufacturing encompasses the production of reagents, kits, calibrators, controls, and other chemical or biological substances used in laboratory-based diagnostic testing. These products enable the detection, measurement, or monitoring of physiological co...

NAICS 325413 – In-Vitro Diagnostic Substance Manufacturing encompasses the production of reagents, kits, calibrators, controls, and other chemical or biological substances used in laboratory-based diagnostic testing. These products enable the detection, measurement, or monitoring of physiological conditions, infectious agents, biomarkers, and genetic markers in clinical specimens such as blood, urine, and tissue. Manufactured under strict quality control standards compliant with CLIA, FDA, and ISO 13485, these in-vitro diagnostic substances are critical to clinical decision-making, public health surveillance, and point-of-care testing infrastructure. In government contracting, this sector supports military medical readiness, veteran healthcare delivery, and biodefense preparedness programs by supplying essential components for automated clinical analyzers and laboratory information systems. Top contractors in this space include MARATHON MEDICAL CORPORATION and TERUMO MEDICAL CORP, both established life sciences manufacturers with deep expertise in sterile, GMP-compliant production of diagnostic reagents. These firms operate as large primes with extensive regulatory compliance capabilities, often serving as sole-source or limited-source suppliers due to the technical complexity and validation requirements of diagnostic substances. The Department of Veterans Affairs and the Department of Defense are the primary federal buyers, procuring these substances to support clinical laboratories in VA medical centers and military treatment facilities. Demand is driven by routine patient diagnostics, deployable medical unit requirements, and biodefense initiatives focused on rapid pathogen identification and health threat monitoring. The competitive landscape is characterized by high regulatory barriers, stringent validation protocols, and long procurement cycles, favoring manufacturers with proven quality systems and established FDA clearances. Opportunities exist for contractors with expertise in assay development, cold-chain logistics, and rapid scale-up of diagnostic materials to meet surge requirements during public health emergencies.

Top Contractors

Companies with the highest total award value under NAICS 325413, ranked by dollars won.

Ranked by total awards
CompanyTotal AwardsContracts
CEPHEID$36.7M80
BIOMERIEUX INC$32.8M110
ROCHE DIAGNOSTICS CORPORATION$18.2M104
QUEST DIAGNOSTICS INCORPORATED$8.0M8
ABBOTT MOLECULAR INC.$5.5M10
WERFEN USA LLC$5.2M60
FISHER SCIENTIFIC COMPANY L.L.C.$5.1M27
BIOFIRE DEFENSE LLC Salt Lake City UT 84107 USA$4.9M1
BECKMAN COULTER, INC$3.4M20
VMRD INC$3.3M4

Top Agencies

Federal agencies directing the most contract spending toward NAICS 325413.

Department Of Veterans Affairs613 awards$122.7M
Department Of Defense418 awards$31.0M
Department Of Health And Human Services115 awards$12.0M
W40M Mrco Pacific6 awards$6.9M
Department Of Agriculture23 awards$4.9M
W40M MRC0 West5 awards$4.7M
W40M USA Hca1 award$2.4M
262-NETWORK Contract Office 22 (36C262)3 awards$2.4M
W40M Mrco Europe2 awards$1.9M
261-NETWORK Contract Office 21 (36C261)1 award$1.1M

Competition

How many companies historically bid on federal awards in NAICS 325413, from bidder counts reported on USAspending.

Usually Single-Bid

Half or more of reported awards drew exactly one bidder, usually a sign of incumbent-held work rather than an open field. · 77,805 reported awards

Median Bidders

1

Per reported award, all-time

Single-Bid Awards

88%

Share of reported awards with one bidder

10+ Bidder Awards

1%

Share of reported awards with 10+ bidders

Reported Awards

0

89% of 87,557 total awards

How this code compares up the NAICS hierarchy. Parent cohorts pool every code under their prefix, so they are the steadier baseline when a 6-digit sample is thin.

Industry FamilyCompetitionMedian BiddersSingle-BidBidder MixReported Awards
325413This Code
In-Vitro Diagnostic Substance Manufacturing
Usually Single-Bid188%
77,80589% of 87,557
32541NAICS Industry
Moderate Competition434%
767,21630% of 2,563,326
3254Industry Group
Pharmaceutical and Medicine Manufacturing
Moderate Competition434%
767,21630% of 2,563,326
325Subsector
Moderate Competition336%
1,583,63736% of 4,450,320
32Sector
Manufacturing
Moderate Competition331%
3,142,44329% of 10,788,432

Bidder counts reported on past federal awards in this NAICS (USAspending). An open opportunity has no bidders yet, so this is the historical norm for similar work, not a fact about this solicitation. Not all awards report bidder counts, and fewer bidders often means incumbent-held work rather than an easier win. Federal reporting of bidder counts fell from ~96% of awards (FY2016) to ~30% (FY2018 onward); the chart shows shares of reported awards, and washed-out stretches mark years with fewer than 30 of them.

Related NAICS Codes

Industries similar to In-Vitro Diagnostic Substance Manufacturing, by shared sector, subsector, and industry group.

Medicinal and Botanical Manufacturing

This U.S. industry comprises establishments primarily engaged in (1) manufacturing uncompounded medi...
325411Same Industry GroupHigh Similarity

Pharmaceutical Preparation Manufacturing

This U.S. industry comprises establishments primarily engaged in manufacturing in-vivo diagnostic su...
325412Same Industry GroupHigh Similarity

Biological Product (except Diagnostic) Manufacturing

This U.S. industry comprises establishments primarily engaged in manufacturing vaccines, toxoids, bl...
325414Same Industry GroupHigh Similarity

Petrochemical Manufacturing

This industry comprises establishments primarily engaged in (1) manufacturing acyclic (i.e., aliphat...
325110Same SubsectorMedium Similarity

Industrial Gas Manufacturing

This industry comprises establishments primarily engaged in manufacturing industrial organic and ino...
325120Same SubsectorMedium Similarity

Synthetic Dye and Pigment Manufacturing

This industry comprises establishments primarily engaged in manufacturing synthetic organic and inor...
325130Same SubsectorMedium Similarity

Other Basic Inorganic Chemical Manufacturing

This industry comprises establishments primarily engaged in manufacturing basic inorganic chemicals ...
325180Same SubsectorMedium Similarity

Ethyl Alcohol Manufacturing

This U.S. industry comprises establishments primarily engaged in manufacturing nonpotable ethyl alco...
325193Same SubsectorMedium Similarity

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NAICS 325413 FAQ

Frequently Asked Questions

NAICS code 325413 covers In-Vitro Diagnostic Substance Manufacturing. 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. Cross-References.

Recently Posted in In-Vitro Diagnostic Substance Manufacturing

NAICS: 325413
New
Federal
6550--PHADIA 250 REAGENT AND CONSUMABLES
Solicitation # 36C24626Q0972
The Department of Veterans Affairs Network Contracting Office 6 intends to award a sole source, firm fixed price contract to Fisher Scientific Company LLC for Phadia 250 reagents and consumables. These supplies are required for the Fayetteville VAMC in North Carolina. Because Fisher Scientific is the original equipment manufacturer and sole authorized source, market research indicates that using a single source is necessary to avoid unacceptable costs or delays in patient care. The procurement falls under NAICS code 325413 for In Vitro Diagnostic Substance Manufacturing. While the government intends to proceed with a sole source award, other capable businesses may submit written notice of their ability to provide the required materials to Cherisse Hall by 12:00pm EDT on September 4, 2026. Submissions must include a company name, address, point of contact, SAM Unique Entity ID, capabilities statement, and past performance. The final decision to compete the acquisition remains at the discretion of the government.
246-NETWORK Contracting Office 6 (36C246)

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about 12 hours ago

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NAICS: 325413
New
Federal
TrueMark, TaqMan, Qubit, and Other Laboratory Consumables
Solicitation # N6311626Q0560
The Naval Health Research Center in San Diego, California, intends to award a sole-source contract to Fisher Scientific Company L.L.C. dba Fisher Healthcare under the statutory authority of 10 U.S.C. 3204(a)(1). This procurement is for a variety of laboratory consumables, including TrueMark, TaqMan, and Qubit assays, primers, controls, and PCR plates. The delivery schedule is specified as as soon as possible after the receipt of the order. Interested parties must be registered in the System for Award Management and complete all necessary FAR and DFARS representations and certifications. Submissions must reference solicitation number N6311626Q0560 and include the company name, full address, CAGE code, and point of contact information. The response deadline for this notice is September 5, 2026.
Naval Health Research Center

POSTED

2 days ago

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in 5 days
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NAICS: 325413
New
Federal
Solicitation 75H70726Q00104 - Laboratory Quality Control Materials - Zuni Comprehensive Community Health Center (ZCCHC)
Solicitation # Solicitation_75H70726Q00104
Solicitation 75H70726Q00104 is issued by the Indian Health Service Albuquerque Area Office to procure laboratory quality control materials and related support for the Zuni Comprehensive Health Center Laboratory in Zuni, New Mexico. This requirement is primarily set aside for Indian Small Business Economic Enterprises under the Buy Indian Act, utilizing a cascading set-aside structure that allows the government to consider other small business categories, such as SDVOSBs and HUBZone certified businesses, if a fair and reasonable price cannot be reached with an ISBEE. Interested vendors must submit a comprehensive quotation consisting of three volumes covering technical capability, past performance, and pricing for the base period and four option periods. Submissions must also include a signed SF 1449 and applicable Indian Economic Enterprise representations. The response deadline for this opportunity is September 3, 2026.
Albuquerque Area Indian Health Svc

POSTED

2 days ago

DEADLINE

in 4 days
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NAICS: 325413
New
Federal
6550-- Blood Bank Cost Per Test
Solicitation # 36C25726Q0870
Solicitation 36C25726Q0870 is a request for quotation for laboratory Blood Bank Cost Per Test services for the VA North Texas Healthcare System. This is an unrestricted, open market procurement under NAICS code 325413. The Department of Veterans Affairs will evaluate proposals based on technical acceptability, past performance, and price. Interested vendors must submit all required documentation to Teresa Arzola via email by September 8, 2026, at 9:00 AM CST. All inquiries must be submitted in writing by September 2, 2026. The contract is governed by FAR Part 12 for commercial items and includes various federal acquisition clauses and provisions regarding labor, trade agreements, and government contracting standards.
257-NETWORK Contract Office 17 (36C257)

POSTED

2 days ago

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in 9 days
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NAICS: 325413
New
Federal
6550--Optilite analyzer reagents
Solicitation # 36C26226Q1425
The Department of Veterans Affairs, through the Network Contract Office 22, is seeking sources for Optilite analyzer reagents under solicitation number 36C26226Q1425. This sources-sought notice is categorized under NAICS code 325413 and is managed by Contract Specialist Carlos Magana. The place of performance for this requirement is located in Tucson, Arizona. Interested parties must submit their responses by the deadline of September 7, 2026, at 4:00 PM.
262-NETWORK Contract Office 22 (36C262)

POSTED

2 days ago

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in 8 days
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NAICS: 325413
Awarded
DIBBS
WATER SAMPLING TEST
Solicitation # SPE2DH-26-T-4177
The contract solicitation SPE2DH-26-T-4177 seeks the procurement of Colilert 18 reagents for water sampling tests designed to detect fecal coliforms and Escherichia coli, with results required within 18 hours. The item is specified as a unit of issue packaged as PG, with each package containing 200 units, and the entire quantity required is one package. Delivery must be completed within 20 days after award, to the destination APO 09094-3219 under FOB Destination terms. Packaging and marking requirements are strictly defined by Medical Marking Standard No. 1 (MMS No. 1), which supersedes MIL-STD-129, and all units must be sealed in suitable containers to prevent damage during transit. Commercial exterior shipping containers are mandatory, and palletization must adhere to DLA Packaging Requirements for Procurement (RP001). The technical specifications are governed by the DLA Master List of Technical and Quality Requirements, identified by R or I numbers, and the product must be free of any additive manufacturing processes unless explicitly authorized, as inclusion of such items disqualifies an offer. All offers must be submitted through the DIBBS portal by the deadline of June 8, 2026, with inquiries directed to Tina Vu at tina.vu@dla.mil. Offerors are required to maintain current registration in the System for Award Management (SAM), provide their CAGE and Unique Entity Identifier, and ensure compliance with small business set-aside provisions under NAICS code 325998. Contract clauses such as 52.204-13, 52.222-36, 52.222-50, and 52.240-93 apply with deviation 2026-00038, mandating maintenance of SAM data, equal opportunity protections, anti-trafficking policies, and cybersecurity safeguards. Invoicing and receiving reports must be processed electronically via Wide Area Workflow (WAWF), and payment instructions require adherence to DFARS and FAR guidelines. The contractor must also submit hazard warning labels compliant with 29 CFR 1910.1200 prior to award, and government identification must be removed from any non-accepted supplies. Inspection and acceptance will occur at the destination with zero tolerance for quantity variance, and the solic
Defense Logistics Agency

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3 days ago

DEADLINE

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NAICS: 325413
New
Federal
BioRad_Lab_Quality_Control_Reagents_Taos_Picuris_Service_Unit
Solicitation # 75H70726Q00102
Solicitation Number 75H70726Q00102 is a request for quotation for BioRad Laboratories Quality Control Reagents to support the Laboratory Department at the Taos-Picuris Indian Health Center in Taos, New Mexico. Issued by the Albuquerque Area Indian Health Service under the Department of Health and Human Services, this acquisition is conducted as a combined synopsis and solicitation for commercial products or services in accordance with FAR Part 12. This procurement is a total Indian Small Business Economic Enterprise set-aside under the Buy Indian Act, featuring a cascading set-aside structure that considers SDVOSBs, HUBZone small businesses, and small disadvantaged businesses if sufficient competition is not met. Interested parties must submit quotes via email to the Contract Administrator by 12:30 pm MDT on September 07, 2026, with all inquiries submitted by September 02, 2026. Offerors must provide self-certification of their status via the Indian Economic Enterprise Representation Form and maintain active registration in the System of Award Management.
Albuquerque Area Indian Health Svc

POSTED

3 days ago

DEADLINE

in 8 days
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NAICS: 325413
New
Federal
6640--Specimen Validity and Drug of Abuse of Abuse Reagent Supplies for the Minneapolis VA Health Care System
Solicitation # 36C26326Q0650_1
The Department of Veterans Affairs Network Contracting Office 23 intends to award a sole source contract to Siemens Healthcare Diagnostics, Inc. for FDA approved specimen validity and Fentanyl reagents. These supplies will be utilized by the Forensic Toxicology Laboratory at the Minneapolis VA Health Care System to perform Fentanyl testing and verify specimen validity through nitrite and creatinine assays. Although this is a notice of intent for a sole source award, interested parties may submit a capabilities statement by September 11, 2026, at 16:00 CT to demonstrate their ability to provide the required services. The government maintains full discretion on whether to compete the contract based on the responses received. If no viable alternatives are identified by the deadline, the Department of Veterans Affairs will proceed with negotiations exclusively with Siemens Healthcare Diagnostics, Inc.
Network Contract Office 23 (36C263)

POSTED

3 days ago

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in 12 days
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NAICS: 325413
Awarded
DIBBS
TEST KIT, E COLI DETECTION
Solicitation # SPE2DS-26-T-330Z
This contract is for the procurement of Immunocard Stat EHEC test kits designed for the qualitative detection of Shiga toxins 1 and 2 produced by E. coli in clinical stool specimens. The kits are engineered to differentiate between toxins 1 and 2 to support optimal patient management in compliance with CDC recommendations. Each unit includes 30 test devices, sample diluent, negative and positive controls, and disposable plastic pipettes. The product maintains high sensitivity and specificity across MAC broth, GN broth, and SMAC plate mediums and requires refrigerated storage between 2 to 8 degrees Celsius. The agreement specifies a non-extendable shelf life of 24 months, with a requirement that no more than three months elapse between the date of manufacture and delivery to the government. Packaging must meet commercial standards and be secured in sealed containers to prevent damage, with all labeling adhering to Medical Marking Standard No. 1. The order is for one unit under solicitation SPE2DS-26-T-330Z, with a delivery requirement of five days after the order is placed.
Defense Logistics Agency

POSTED

4 days ago

DEADLINE

N/A
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NAICS: 325413
New
Federal
Primary Human Trophoblast Cells
Solicitation # 75F40126Q134903
The Department of Health and Human Services, through the FDA Office of Acq Grant Svcs, is seeking the procurement of Primary Human Trophoblast Cells under solicitation number 75F40126Q134903. This combined solicitation is categorized under NAICS code 325413 and is managed by Howard Nesmith. The opportunity was posted on August 26, 2026, with a response deadline of August 31, 2026. While the contracting office is located in Rockville, Maryland, the designated place of performance is in Jefferson, Arkansas.
FDA Office Of Acq Grant Svcs

POSTED

4 days ago

DEADLINE

in about 18 hours
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NAICS: 325413
New
Federal
6550--Immunology Testing
Solicitation # 36C26226Q1412
The Department of Veterans Affairs, through Network Contract Office 22, is soliciting bids for the procurement of immunology testing reagents and supplies for the Greater Los Angeles Healthcare System. This combined contract, identified by solicitation number 36C26226Q1412 and NAICS code 325413, focuses on providing specific BioRad brand products and equipment, including ANA testing reagents, to be used on BioPlex instrumentation. The successful offeror will be responsible for supplying these materials while adhering to strict operational hours and comprehensive security requirements, including federal information security standards and personnel clearance protocols. The procurement process requires detailed company information and pricing for a specific list of Contract Line Item Numbers (CLINs) that outline the necessary part numbers and salient characteristics of the required BioRad equipment. Performance of the contract will take place in Los Angeles, California. Interested parties must submit their responses by September 2, 2026, to the primary point of contact, Contract Specialist Carlos Magana.
262-NETWORK Contract Office 22 (36C262)

POSTED

4 days ago

DEADLINE

in 3 days
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NAICS: 325413
New
Federal
NNMC Test Kits and Technical Services for Roche Equipment
Solicitation # IHS1520579
The Navajo Area Indian Health Service Shiprock Service Unit intends to award a sole source, firm-fixed-price contract to Roche Diagnostics Corporation for test kits, supplies, and technical services. This restriction of competition is based on the fact that Roche Diagnostics is the only vendor capable of providing materials compatible with the equipment currently installed at the facility. The procurement falls under NAICS code 325413 for In-Vitro Diagnostic Substance Manufacturing and will be conducted using simplified procedures. The period of performance is set for 12 months from the date of the award. While this notice is not a formal solicitation, interested vendors may submit capability statements to Bertina Jones by September 11, 2026, at 10:00 am MDT. The government will use any received information to determine if a competitive procurement is necessary, though a formal solicitation will not be issued.
Navajo Area Indian Health Svc

POSTED

4 days ago

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in 12 days
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