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NAICS Code· 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.

40
Active Contracts
$217.3M
Total Obligations (12mo)
1.4K
Awarded Contracts (12mo)
204
Contractors Awarded (12mo)
-90.4%
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$37.5M82
BIOMERIEUX INC$31.2M112
ROCHE DIAGNOSTICS CORPORATION$20.9M112
QUEST DIAGNOSTICS INCORPORATED$8.0M8
ROCHE DIAGNOSTICS CORPORATION Indianapolis IN 46256 USA$6.2M3
ABBOTT MOLECULAR INC.$5.9M11
FISHER SCIENTIFIC COMPANY L.L.C.$5.0M28
BIOFIRE DEFENSE LLC Salt Lake City UT 84107 USA$4.9M1
ABBOTT LABORATORIES INC.$4.5M1
WERFEN USA LLC$3.6M60

Top Agencies

Federal agencies directing the most contract spending toward NAICS 325413.

Department Of Veterans Affairs628 awards$126.4M
Department Of Defense477 awards$33.4M
W40M Mrco Pacific9 awards$13.3M
Department Of Health And Human Services141 awards$12.8M
Defense Health Agency1 award$4.5M
261-NETWORK Contract Office 21 (36C261)3 awards$4.5M
W40M MRC0 West8 awards$4.1M
257-NETWORK Contract Office 17 (36C257)3 awards$3.7M
Army Medical Resources Acq Activity1 award$2.9M
W40M USA Hca2 awards$2.7M

Related NAICS Codes

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

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

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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

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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

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Other Basic Inorganic Chemical Manufacturing

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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
Awarded
DIBBS
TEST KIT, CORONAVIRUThe Defense Logistics Agency has awarded a contract to SZY HOLDINGS, LLC under solicitation SPE2DS-26-T-203Q, with an award date of July 15, 2026, and a total contract value of $22.88. The sole line item involves a TEST KIT, CORONAVIRU identified by NSN 6550016976662 and PR 7017372253, sourced under NAICS code 325413, which corresponds to pharmaceutical and biological product manufacturing. The award is classified as a federal action with no specific set-aside designation, and performance location details are not specified beyond a United States country code. Point of contact for the contract is Tiffany Parker, reachable via email and phone, with the full contract details accessible through the DIBBS portal.
Defense Logistics Agency

POSTED

1 day ago

CLOSED

3 days ago
View Details
NAICS: 325413
New
DIBBS
CONTROL, BLOOD CHEMIThis contract specifies the procurement of CONTROL, BLOOD CHEMISTRY reagents for use with the i-STAT PT PLUS cartridge on the i-STAT 1 analyzer system, intended for coagulation testing in medical settings. The product is supplied in boxes of ten 1.0 mL units, with a total of six boxes required under purchase request 7017447545. The item has a non-extendable shelf life of 12 months, and delivery to the government must occur within one month of manufacture. Storage requirements mandate refrigeration between 2°C to 8°C (36°F to 46°F) with no freezing allowed. All packaging must comply with Medical Marking Standard No. 1, replacing MIL-STD-129, and each unit must be labeled with the date of manufacture, expiration date, contract number, and lot number. The product is subject to DLA packaging requirements and must be shipped in commercial containers that ensure safe delivery at the lowest possible rate to the designated delivery point at Camp Lejeune, NC 28542-0128. Government identification must be removed from non-accepted supplies, and the item is classified as a TYPE I (CODE H) controlled medical supply under solicitation SPE2DS-26-T-237E. Bidders must clearly state the source and part number being offered, and all technical and quality requirements are governed by the DLA Master List referenced in the solicitation. The solicitation was posted on July 15, 2026, with responses due by July 21, 2026, and delivery is required within five days of award.
MEDICAL SUPPLY CHAIN MD SURG FSF

POSTED

1 day ago

DEADLINE

in 5 days
View Details
NAICS: 325413
Awarded
DIBBS
CONTROL, BLOOD CHEMISTRYThe Defense Logistics Agency has awarded a contract to SZY HOLDINGS, LLC under solicitation SPE2DS-26-T-190F, with an award date of July 15, 2026, and a total value of $2,435.00. The contract is for the supply of CONTROL, BLOOD CHEMISTRY, identified by NSN 6550017374380 and PR 7017324177, supporting defense medical logistics needs. The North American Industry Classification System code for this procurement is 325413, indicating it is related to pharmaceutical and biological product manufacturing. The award is a federal action under the Department of Defense with no specified set-aside classification, and performance location details are not provided. Primary point of contact for the contract is Anh Lam, reachable via email at anh.lam@dla.mil or phone at 215-737-7477. The contract details are publicly accessible through the DIBBS portal using the reference number SPE2DS26P2419.
Defense Logistics Agency

POSTED

1 day ago

DEADLINE

N/A
View Details
NAICS: 325413
New
DIBBS
CALIBRATOR SET, HUMAThe contract is for the procurement of Calibrator Sets for Human Chorionic Gonadotropin (hCG), specifically designed for use with the VITROS ECI/ECIQ, VITROS 3600, and VITROS 5600 immunodiagnostic systems to enable quantitative measurement of hCG and its B-subunit in human serum and plasma. Each package contains three sets of calibrators labeled as Level 1, 2, and 3, along with a calibration card, protocol card, and 24 bar code labels for system integration. The product requires refrigerated storage between 2 to 8 degrees Celsius and must not be frozen. The unit of issue is PG, with four packages ordered totaling twelve individual calibrator sets. The item has a non-extendable shelf life of six months, with no more than two weeks allowed to have passed from the date of manufacture to the date of government delivery. All packaging and labeling must comply with Medical Marking Standard No. 1 (MMS No. 1), replacing MIL-STD-129, and must clearly display the date of manufacture, expiration date, contract number, and lot number. Packaging must be commercial grade, sealed, and capable of protecting contents from damage, with exterior containers suitable for safe delivery by common carrier at the lowest cost to the designated delivery point. The procurement is governed under solicitation SPE2DS-26-T-239V, issued by the Department of Defense through the Medical Supply Chain MD Surg FSF, with delivery required within 20 days of award, and the contract incorporates technical, quality, and packaging requirements from the DLA Master List as referenced.
MEDICAL SUPPLY CHAIN MD SURG FSF

POSTED

1 day ago

DEADLINE

in 5 days
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NAICS: 325413
New
DIBBS
Medical Diagnostic Test Kit SupplierThe contract seeks the supply of FDA-cleared Chlamydia trachomatis detection kits, each containing 50 individual tests, to be delivered in full compliance with all regulatory labeling, safety, and shelf-life standards. The equipment must meet rigorous diagnostic accuracy and quality control requirements as mandated by the U.S. Food and Drug Administration, ensuring reliable and consistent performance in clinical settings. This is a subcontract under the Department of Defense’s Medical Supply Chain MD SURG FSF, with performance required at Hampton, Virginia, ZIP 23665-2040. The solicitation was posted on July 14, 2026, with a firm deadline for responses on July 20, 2026, and is identified under NAICS code 325413, which pertains to pharmaceutical and medicine manufacturing. All submissions must align with the contractual obligations tied to regulatory compliance, packaging integrity, and logistical timelines to support operational medical readiness.
MEDICAL SUPPLY CHAIN MD SURG FSF

POSTED

2 days ago

DEADLINE

in 4 days
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NAICS: 325413
New
DIBBS
TEST KIT, CHLAMYDIA TRAThe contract is for a qualitative direct immunofluorescence test kit designed for the detection of Chlamydia trachomatis in human urogenital and ocular specimens, as well as for confirming Chlamydiae in cell culture. The kit includes two positive control slides, mounting fluid, and the Chlamydia test reagent, specifically identified by NSN/Part Number 6550-01-725-3600, with a single kit ordered under purchase request 7017466994. Delivery is scheduled within 20 days after award. The solicitation was issued under contract number SPE2DS-26-T-230P, posted on July 14, 2026, with responses due by July 20, 2026. It falls under NAICS code 325413, pertains to federal procurement, and is managed by the Department of Defense through the Medical Supply Chain MD Surg FSF. The place of performance is listed as Hampton, Virginia, with Mary-Kathryn Donahue as the primary point of contact, reachable via email and phone provided.
MEDICAL SUPPLY CHAIN MD SURG FSF

POSTED

2 days ago

DEADLINE

in 4 days
View Details
NAICS: 325413
Awarded
DIBBS
TEST KIT, HUMAN IMMUNODEFICIENCY VIRUS DEThe Defense Logistics Agency has awarded CENMED ENTERPRISES INC, with CAGE code 1WAS9, a contract valued at $525.00 for the procurement of a Human Immunodeficiency Virus test kit identified by NSN 6550016921809 and procurement request number 7017415538. The award, issued under solicitation SPE2DS-26-T-215H, was officially posted on July 14, 2026, and falls under the NAICS code 325413, which corresponds to pharmaceutical and medicine manufacturing. The contract is classified as a federal award with no specific set-aside designation, and the place of performance is not specified beyond the United States. Primary point of contact for the contract is Mary-Kathryn Donahue, reachable via phone at 215-737-3008 or email at mary-kathryn.donahue@dla.mil. The contract details are accessible through the DIBBS system using the award number SPE2DS26V7636.
Defense Logistics Agency

POSTED

2 days ago

DEADLINE

N/A
View Details
NAICS: 325413
New
DIBBS
CONTROL LOOP SETThe CONTROL LOOP SET is a microbiological control culture containing Streptococcus pyogenes ATCC 19615, packaged in units of five per package and designated as PG. It requires refrigerated storage between 2 and 8 degrees Celsius and must not be frozen. The product has a non-extendable shelf life of 15 months, with no more than two months allowed to have elapsed from the date of manufacture to the date of delivery to the government. Labeling must include the date of manufacture, expiration or retest date, and the contract or lot number, in strict compliance with the latest revision of Medical Marking Standard No. 1, which supersedes MIL-STD-129. Packaging must meet commercial standards, with each unit sealed in a protective container and shipped in suitable exterior packaging to ensure safe delivery at the lowest carrier rate. All labeling and packaging must adhere to the DLA Medical Marking Standard and the DLA Packaging Requirements for Procurement. The item is subject to technical and quality requirements referenced in the DLA Master List, and covered defense information may apply. The NSN is 6550-01-691-8597, with a delivery requirement of 20 days ADO under contract SPE2DS-26-T-230W, solicited by the Department of Defense’s Medical Supply Chain for delivery to Hampton, VA.
MEDICAL SUPPLY CHAIN MD SURG FSF

POSTED

2 days ago

DEADLINE

in 4 days
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NAICS: 325413
New
DIBBS
I-STAT HS-TNI CARTRThe I-STAT HS-TNI Cartridge is a single-use diagnostic device designed for rapid, quantitative measurement of cardiac troponin-I in whole blood or plasma, delivering results in approximately 15 minutes when used with the I-STAT 1 Analyzer. Each unit is packaged in a commercial-grade sealed container that ensures protection from damage and breakage during transit, and must be shipped in commercial exterior packaging compatible with common carrier standards to ensure safe, cost-effective delivery to the specified point. All items must comply with Medical Marking Standard No. 1, which replaces MIL-STD-129, and labels must clearly indicate the date of manufacture, expiration date, contract number, and lot number in accordance with MMS1C guidelines. The cartridges require refrigeration storage between 2 to 8 degrees Celsius and must not be frozen. Shelf life is strictly limited to eight months from the date of manufacture, with no more than one month elapsed between manufacturing and government delivery. The item is identified by NSN 6550-01-729-3540 and is procured under contract SPE2DS-26-T-229S, subject to all technical and quality requirements referenced in the DLA Master List, including packaging standards and the removal of government identification from non-accepted supplies. Bidders must specify the source and part number being supplied, with delivery required within 20 days of award.
MEDICAL SUPPLY CHAIN MD SURG FSF

POSTED

2 days ago

DEADLINE

in 4 days
View Details
NAICS: 325413
Closed
SLED
HHS0017640 DNA Extraction Reagents Newborn ScreeningThe Texas Department of State Health Services is soliciting bids for a five-year contract to supply DNA extraction reagents essential for the state’s Newborn Screening Program, specifically to support screening for Severe Combined Immunodeficiency Disorder and Spinal Muscular Atrophy using dried blood spot samples. The contract requires two specific reagents: QuantaBio Extracta DBS DNA extraction buffer at 1x concentration, part number 95171-500 in 500 mL units, estimated at 450 units annually, and QuantaBio PerfeCTa qPCR ToughMix UNG, Low ROX at 2x concentration, part number 95140-05K in 50 mL units, estimated at 136 units annually. All products must meet exact technical specifications, and any proposed substitutions must be accompanied by sufficient documentation demonstrating equivalency or superior performance; bids lacking this documentation will be disqualified. Products must be shipped as single lots, remain free of rework, seconds, or previously refused items, and be packaged to maintain manufacturer-specified temperature conditions during transit. Deliveries must be complete, with no mixing of brands or split shipments unless explicitly requested, and must arrive on time according to HHSC’s schedule. The contract has an initial term from September 1, 2026, through August 31, 2027, with up to four optional one-year renewals extending through August 31, 2031, and a potential one-year extension beyond that. Bids must be submitted via email, the HHS Online Bid Room, or hand-delivered on a USB drive by the deadline of July 15, 2026, at 10:30 AM CT; late responses are not accepted. All submissions must be in Microsoft Office or Adobe PDF formats, and responses submitted by fax or unauthorized methods will be rejected. Bidders must provide their SAM.gov Unique Entity Identifier, Federal Employer Identification Number, Texas Identification Number, Texas Franchise Tax Number, and Texas Secretary of State Filing Number, and must certify they are not suspended, debarred, or ineligible under state or federal law, including compliance with civil rights statutes like Title VI and Section 504 of the Rehabilitation Act. Pricing must be firm, fixed, and all-inclusive, covering labor, materials, and associated costs, with no additional charges permitted on invoices. Payment is governed by the Texas Prompt Payment Act, requiring
Department of State Health Services

POSTED

2 days ago

CLOSED

1 day ago
View Details
NAICS: 325413
New
Federal
6550--NOITSS - Zeus Scientific Borrelia MTTT Lyme Elisa Testing
241-NETWORK Contract Office 01 (36C241)

POSTED

2 days ago

DEADLINE

in 6 days
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NAICS: 325413
Awarded
Federal
Notice of Award to Meridian Bioscience
W40M MRC0 West

POSTED

2 days ago

DEADLINE

N/A
View Details

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