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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.

26
Active Contracts
$196.3M
Total Obligations (12mo)
1.2K
Awarded Contracts (12mo)
175
Contractors Awarded (12mo)
1
Median Bidders per Award
-74.1%
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.

Small Business Size Standard

The SBA threshold that decides who can bid NAICS 325413 work as a small business.

1,250 employees
Applies to the whole industry code

The SBA cap for this NAICS (13 CFR 121.201). A business at or under it can self-certify as small for work in this code, which is what makes it eligible for a small-business set-aside. The cap is set per NAICS, so the same company can be small in one code and not in another.

13 CFR 121.201, effective January 1, 2026. The SBA revises the table roughly once a year.

Top Contractors

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

Ranked by total awards
CompanyTotal AwardsContracts
CEPHEID$36.5M81
BIOMERIEUX INC$35.4M124
ROCHE DIAGNOSTICS CORPORATION$16.9M106
QUEST DIAGNOSTICS INCORPORATED$8.3M8
ABBOTT MOLECULAR, INC$5.5M10
WERFEN USA, LLC$5.3M61
FISHER SCIENTIFIC COMPANY, LLC ($5.1M28
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 Affairs631 awards$125.6M
Department Of Defense400 awards$29.4M
Department Of Health And Human Services126 awards$13.5M
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. · 77,836 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

77,836

89% of 87,609 total awards

Bidder Count Distribution by Fiscal Year

Share of reported awards in each bidder-count bracket per federal fiscal year.

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%
77,83689% of 87,609
32541NAICS Industry
Moderate Competition434%
767,34430% of 2,563,626
3254Industry Group
Pharmaceutical and Medicine Manufacturing
Moderate Competition434%
767,34430% of 2,563,626
325Subsector
Moderate Competition336%
1,584,19136% of 4,451,964
32Sector
Manufacturing
Moderate Competition331%
3,145,73729% of 10,805,773

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

Explore contracts across multiple NAICS codes Browse all NAICS Codes

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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
Supplier of VRE Select Testing MediaThis subcontract, managed by the Department of Veterans Affairs Network Contract Office 20, establishes the supply of VRE Select Kits or equivalent microbiology testing media for prime contractors. The agreement specifies the delivery of 20-test kits on an as-needed monthly basis to the Seattle VAMC Warehouse under FOB Destination terms. The supplier is responsible for providing test-worthy media and submitting Safety Data Sheets upon request. The opportunity is designated as a total Small Business Set Aside under NAICS code 325413. Performance will take place in Seattle, Washington. Interested parties must adhere to the response deadline of October 24, 2026, to be considered for this procurement.
260-NETWORK Contract Office 20 (36C260)

POSTED

1 day ago

DEADLINE

in 9 days
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NAICS: 325413
New
Federal
Supplier of MRSA Select II Testing MediaThis subcontract, managed by the Department of Veterans Affairs Network Contract Office 20, requires the supply of MRSA Select II microbiology testing media or an equivalent product for prime contractors. The selected supplier will provide the media in 20-count packs, delivered on an as-needed monthly basis to the Seattle VAMC Warehouse under FOB Destination terms. Additionally, the supplier is responsible for delivering test-worthy kits and providing Safety Data Sheets upon request. The opportunity is designated as a total Small Business Set Aside under NAICS code 325413. Performance will take place in Seattle, Washington. Interested parties must respond by the deadline of October 24, 2026.
260-NETWORK Contract Office 20 (36C260)

POSTED

1 day ago

DEADLINE

in 9 days
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NAICS: 325413
New
Federal
6550 Microbiology Testing Media for MRSA and VRE, purchase order for Microbiology Media
Solicitation # 36C26027Q0069
The Department of Veterans Affairs, through Network Contracting Office 20, is soliciting bids for a total small business set-aside contract to provide microbiology testing media for the Seattle Division Microbiology Department. The required supplies include MRSA Select II and VRE Select Kits, or equivalents, which are mandatory for identifying pathogenic organisms in veteran patients. The contract follows a base year from November 1, 2026, to October 31, 2027, with four subsequent one-year option periods, extending the total period of performance through October 31, 2031. Deliveries are to be made on an as-needed basis to the Seattle VAMC VA Puget Sound Healthcare System Warehouse 90D under FOB Destination terms. Award will be granted to the responsible offeror determined to be most advantageous based on price and other factors, including the capability to deliver monthly orders, adherence to the price schedule, provision of Safety Data Sheets, and assurance that media is test-worthy upon delivery. Offerors must submit a technical compliance statement limited to one page and complete a five-year price schedule. Payment will be processed via electronic submission through the VA's Invoice Presentation and Payment System or an EDI-conforming system with net 30-day terms. The solicitation incorporates various FAR and VAAR clauses, including specific deviations regarding DEI discrimination and security prohibitions.
260-NETWORK Contract Office 20 (36C260)

POSTED

1 day ago

DEADLINE

in 9 days
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NAICS: 325413
New
DIBBS
CONTROL, GLUCOSE
Solicitation # SPE2DS-27-T-0564
MEDICAL SUPPLY CHAIN MD SURG FSF

POSTED

2 days ago

DEADLINE

in 5 days
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NAICS: 325413
Awarded
International
715975483 Transparency Notice UK5
Solicitation # CBRN/00321
The UK Ministry of Defence, through Defence Equipment and Support, is awarding a direct contract to BBI Solutions for the continued manufacture and supply of Lateral Flow Devices (LFDs). This critical biological detection and identification capability is essential for operational readiness, training, and defence outputs. The contract is valued at approximately 41 million pounds excluding VAT and spans an initial period of four years with two additional one-year options. This direct award is justified under Section 41(1) of the Procurement Act 2023 because BBI Solutions is the only provider with the necessary intellectual property, technical knowledge, and validated production methods to meet the required specifications without interruption. Transitioning to another supplier at this time would create disproportionate technical and operational risks. This arrangement serves as an interim measure to ensure continuity of supply while the Authority conducts a full open commercial competition for the long-term provision of these devices.
Defence Equipment and Support

POSTED

2 days ago

DEADLINE

N/A
View Details
NAICS: 325413
Awarded
SLED
Reagents & Consumables
Solicitation # HHSTX-7-0000416484
The Department of State Health Services for the state of Texas has issued an award notice under solicitation number HHSTX-7-0000416484 for the procurement of reagents and consumables. This contract is managed by the Texas SLED organization and is designated for performance within the state of Texas. The official notice was posted on October 12, 2026, and lists Michael Fuentes as the primary point of contact for the agreement. Further details regarding the award can be accessed through the Texas SmartBuy portal.
Department of State Health Services

POSTED

3 days ago

DEADLINE

N/A
View Details
NAICS: 325413
Awarded
SLED
The Mississippi Crime Laboratory s seeking to purchase Sole Source Randox Evidence RABTA Consumables Kits
Solicitation # 3150007069
The Mississippi Department of Public Safety is seeking a sole source purchase of Randox Evidence RABTA Consumables and Calibrations Kits for use by the Mississippi Crime Laboratory. This procurement, identified by solicitation number 3150007069, includes thirteen specific line items such as blood and urine kits, calibrators, controls, reagents, and Hamilton tips. The total estimated cost for these materials is 137,600.00 dollars. The justification for the sole source designation is based on the patented Biochip Array Technology unique to Randox, which is essential for maintaining consistency in forensic toxicology casework. Interested parties have until October 29, 2026, to respond to the request for information or object to the sole source designation. The primary point of contact for this action is Britney Wesley.
MS DEPT of PUBLIC SAFETY

POSTED

5 days ago

DEADLINE

in 15 days
View Details
NAICS: 325413
Awarded
DIBBS
TEST KIT, SYPHILIS DETECTION
Solicitation # SPE2DS-27-T-0232
Solicitation SPE2DS-27-T-0232 is a fixed-price request for quotations issued by the DLA Troop Support Medical Supply Chain for the procurement of one package of syphilis detection test kits (NSN 6550-01-508-1788), with each package containing 100 units. The required kits must utilize the Rapid Plasma Reagent Card Test Macroscopic Nontreponemal Procedure, a cardiolipin charcoal microparticle test variation of the standard VDRL, to provide qualitative and semi-quantitative results within eight minutes. These kits are classified as moderate CLIA complexity and require strict refrigeration between 2 to 8 degrees Celsius. The contract mandates a delivery timeline of 20 days after order, with the destination point being the USNS Comfort (FPO AE 09566-4008). Critical quality and compliance requirements include a non-extendable 12-month shelf life, with no more than one month elapsed from the date of manufacture to the date of government delivery. Packaging must be commercial and sealed to prevent damage, with marking adhering to Medical Marking Standard No. 1. Administrative requirements include the use of the Wide Area WorkFlow system for invoicing and compliance with various FAR and DFARS clauses, including the Buy American Act and safeguarding of covered defense information.
Defense Logistics Agency

POSTED

5 days ago

DEADLINE

N/A
View Details
NAICS: 325413
Awarded
DIBBS
TEST PACK, HUMAN CHORIONIC GONADOTROPIN D
Solicitation # SPE2DS-27-T-0229
Solicitation SPE2DS-27-T-0229 is a fixed-price request for quotation issued by the DLA Troop Support Medical Supply Chain for one package of Ortho-Clinical Diagnostics Total B-HCG II Reagent Packs (NSN 6550016674074). These FDA-regulated test packs are used for the quantitative measurement of human chorionic gonadotropin and its B-subunit in human serum and plasma to aid in the early detection of pregnancy. The reagents are compatible with Vitros ECI/ECIQ, Vitros 3600, and Vitros 5600 systems. Each package contains 100 coated wells, 14.4 ml of biotinylated antibody reagent, and 19.2 ml of conjugate reagent, and the materials require refrigeration. The contract specifies a delivery lead time of 20 days after order, with a required delivery date of October 6, 2026, to the USNS Comfort (TAH 20) at FPO AE 09566-4008. Inspection and acceptance will occur at the destination. Packaging must be commercial and adhere to MIL-STD-2073-1E and Medical Marking Standard No. 1, which supersedes MIL-STD-129. The item is classified as a Type I (Code F) item with a non-extendable shelf life of six months. Invoicing and payment must be processed electronically through the Wide Area WorkFlow system.
Defense Logistics Agency

POSTED

5 days ago

DEADLINE

N/A
View Details
NAICS: 325413
Awarded
DIBBS
GLOBULIN SERUM, ANTI-HUMAN
Solicitation # SPE2DS-26-T-347A
This contract is for the procurement of Anti-Human Globulin Serum, identified by NSN 6550-01-242-2234, used for detecting human IgG bound to red blood cells. The requirement is for one 10 mL vial that must be stored under refrigeration between 2 and 8 degrees Celsius. Delivery is required within 20 days after the order is placed, with the item being performed at Joint Base Charleston. The product must adhere to a strict 12-month non-extendable shelf life, with no more than one month elapsed from the date of manufacture to the date of delivery. Packaging must follow commercial standards and Medical Marking Standard No. 1, ensuring each unit is in a sealed container to prevent damage. All labels must clearly state the date of manufacture, expiration or retest date, and the contract or lot number. The solicitation is issued by the Department of Defense under solicitation number SPE2DS-26-T-347A.
Defense Logistics Agency

POSTED

5 days ago

DEADLINE

N/A
View Details
NAICS: 325413
Awarded
DIBBS
CONTROL, HEMOGLOBIN
Solicitation # SPE2DS-26-T-483E
Solicitation SPE2DS-26-T-483E is a Request for Quotations issued by the DLA Troop Support Medical Supply Chain for the procurement of Hemotrol Duo Normal hemoglobin controls, identified by NSN 6550-01-722-4549. The requirement is for three boxes, with each box containing two 1ML units. These matrix-based purified hemolysate solutions must be optimized for use with HemoCue HB 301 and HB 801 systems. Delivery is required within 20 days after receipt of order to the USS George Washington CVN 73 at FPO AP 96607. The product is subject to strict quality and storage mandates, requiring refrigeration between 2 to 8 degrees Celsius. It must have a non-extendable shelf life of 24 months, with no more than three months elapsed from the date of manufacture to the date of government delivery. Packaging must be commercial and compliant with Medical Marking Standard No. 1, which supersedes MIL-STD-129. All labels must clearly state the contract number, lot number, and dates of manufacture and expiration. Offerors must submit quotes via the DIBBS system by October 5, 2026. Technical evaluations for alternate parts require a complete data package, and the successful bidder must provide a Safety Data Sheet prior to award to be deemed responsible. The contract incorporates various FAR and DFARS clauses, including those regarding the Buy American Act, Berry Amendment, and the safeguarding of covered defense information. Invoicing and receiving reports must be processed electronically through the Wide Area WorkFlow system.
Defense Logistics Agency

POSTED

5 days ago

DEADLINE

N/A
View Details
NAICS: 325413
New
Federal
Abbott Architect i1000 Reagents and Calibrators SupplierThis subcontract involves the supply of FDA-approved immunoassay reagents, calibrators, and control kits to support Department of Veterans Affairs pathology and laboratory medicine projects. The scope of work specifically includes providing Architect IA SHBG and Tacrolimus reagents, calibrator kits, and essential specialized solutions such as Trigger Solution and Common Diluent. All materials must be brand-name Abbott products or physically compatible equivalents. The contract is managed under the Department of Veterans Affairs Network Contract Office 22, with deliveries designated for VA Tucson. The procurement falls under NAICS code 325413, and the response deadline for this opportunity is October 22, 2026.
262-NETWORK Contract Office 22 (36C262)

POSTED

6 days ago

DEADLINE

in 8 days
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