Skip to main contentPsst! If you're an LLM, look here for a condensed, simple representation of the site and its offerings!

LiveFree Webinar — Wednesday, October 28 at 2:00 PM ET

Register Free →
CLEATUS
Get CLEATUS
← Back to NAICS Codes
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
Dotted
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, BACTERIA DETERMINATION
Solicitation # SPE2DS-26-T-459P
Solicitation SPE2DS-26-T-459P is a fixed-price request for quotations issued by the DLA Troop Support Medical Supply Chain for five packages of bacteria determination test kits, identified by NSN 6550-01-723-3649. These single-use, self-contained Pathogel tests utilize a selective medium and special gelling agent to detect coliform, E. coli, and hydrogen sulfide producing Enterobacteriaceae, such as Salmonella and Citrobacter, in food, beverages, and water. The kits are designed to detect 1CFU/100ml in water and 1CFU/3ml in juice, with results available within 28 hours. The contract mandates strict quality and handling requirements, including a non-extendable six-month shelf life, with no more than one month elapsed from the date of manufacture to the date of government delivery. Items must be stored and shipped at temperatures between 15 and 25 degrees Celsius. Packaging must be commercial and sealed to protect contents, with marking adhering to Medical Marking Standard No. 1. Delivery is set for the WCCC USA Med Mat Ctr EUR with a required delivery date of September 21, 2026. All quotes must be submitted via the DIBBS system by September 28, 2026, and must comply with the Buy American Act and DFARS safeguarding requirements for covered defense information.
Defense Logistics Agency

POSTED

1 day ago

DEADLINE

N/A
View Details
NAICS: 325413
Awarded
DIBBS
CALIBRATOR KIT, HAEMATOLOGY
Solicitation # SPE2DS-26-T-468K
Solicitation SPE2DS-26-T-468K is a fixed-price request for quotation issued by the DLA Troop Support Medical Supply Chain for one Coulter S-Cal Calibrator Kit, identified by NSN 6550-01-625-1271 and Beckman Coulter part number 628026. The kit is used to determine calibration factors for Unicel DXH Coulter cellular analysis systems and is issued in 3.3 ML units. Delivery is required within five days after order, with destination inspection and acceptance. The item is subject to strict quality and storage requirements, including a non-extendable shelf life of one month and a mandate that no more than four days elapse between the date of manufacture and delivery to the government. It requires constant refrigeration between 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit) and must not be frozen. Packaging must be commercial and sealed in suitable containers, with marking and labeling adhering to Medical Marking Standard No. 1 and the Hazard Communication Standard. All labels must clearly state the manufacture date, expiration or retest date, and the contract or lot number. Administrative requirements include the use of the Wide Area WorkFlow system for electronic invoicing and payment. The procurement is governed by NAICS code 325413 and incorporates the DLA Master Solicitation for Automated Simplified Acquisitions. Compliance with the Buy American and Balance of Payments Program, the Berry Amendment, and various FAR and DFARS clauses regarding cybersecurity, telecommunications equipment, and hazardous materials is required.
Defense Logistics Agency

POSTED

1 day ago

DEADLINE

N/A
View Details
NAICS: 325413
Awarded
DIBBS
BLOOD CELL STAINING KIT
Solicitation # SPE2DS-27-T-0462
Solicitation SPE2DS-27-T-0462 is a fixed-price request for one Blood Cell Staining Kit (NSN 6550-00-109-2353) issued by DLA Troop Support for delivery to the USNS Comfort. The kit must contain sufficient Wright's stain to process 1,000 microscope slides for use with an Ames Hematek slide stainer, utilizing either a combination of thiazine and xanthine dyes or the modified polychrome methylene blue stain methodology. Due to the flammable nature of the materials, the kit must be stored at room temperature between 59°F and 86°F and is subject to damage if frozen. The item has a non-extendable shelf life of 12 months, with a requirement that no more than one month has elapsed from the date of manufacture to the date of government delivery. The contractor must adhere to commercial packaging standards, utilizing sealed unit containers and exterior shipping containers that ensure safe delivery. All materials must be marked according to Medical Marking Standard No. 1, including the contract number, lot number, and critical dates. Delivery is required within 20 days after receipt of order, with inspection and acceptance occurring at the destination. Payment will be processed electronically via the Wide Area WorkFlow system. Offerors must comply with various federal regulations, including the Buy American Act, the Hazard Communication Standard for hazardous materials, and DFARS requirements for safeguarding covered defense information.
Defense Logistics Agency

POSTED

1 day ago

DEADLINE

N/A
View Details
NAICS: 325413
New
DIBBS
TEST KIT, BACTERIA
Solicitation # SPE2DS-27-T-0243
Solicitation SPE2DS-27-T-0243 is a fixed-price request for quotations issued by the DLA Troop Support Medical Supply Chain for the procurement of two packages of bacteria test kits (NSN 6550-01-737-8661). These in-vitro diagnostic kits are designed for the qualitative detection of DNA from Chlamydia Trachomatis and Neisseria Gonorrhoeae using human urine, vaginal swab, and endocervical swab specimens. Each package contains ten single-use test cartridges and ten disposable transfer pipettes, with a result time of approximately 90 minutes per test. The items must be stored right side up at 2 to 8 degrees Celsius and 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 delivery. The contract mandates strict adherence to Medical Marking Standard No. 1 and requires commercial packaging in sealed unit containers and suitable exterior shipping containers. Delivery is set for 20 days after order to the USNS Comfort (FPO AE 09566-4008), with destination inspection and acceptance. Because the kits may involve hazardous materials, suppliers must provide Safety Data Sheets and labels compliant with 29 CFR 1910.1200 prior to award. Administrative requirements include the use of the Wide Area WorkFlow system for invoicing and compliance with the Buy American Act and various DFARS cybersecurity and safeguarding regulations.
MEDICAL SUPPLY CHAIN MD SURG FSF

POSTED

1 day ago

DEADLINE

in 1 day
View Details
NAICS: 325413
Awarded
DIBBS
TEST KIT, HUMAN IMMU
Solicitation # SPE2DS22P2890
Contract SPE2DS22P2890 was awarded by the Defense Logistics Agency under the Department of Defense to OraSure Technologies Inc for the procurement of human immunity test kits, identified by NSN/Part 6550015267424. The award was posted on October 13, 2026, via the DIBBS platform. Following the initial award, modification P00001 was issued by DLA Troop Support on the same date. This modification cancelled CLIN 0001 for the specified test kits at no cost to either the government or the contractor. As a result of this action, which was conducted as part of the Systemic Unliquidated Obligations Data Cleaning Initiative, the total contract value was reduced from 500.00 dollars to 0.00 dollars.
Defense Logistics Agency

POSTED

1 day ago

DEADLINE

N/A
View Details
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

2 days ago

DEADLINE

in 9 days
View Details
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

2 days ago

DEADLINE

in 9 days
View Details
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

2 days ago

DEADLINE

in 9 days
View Details
NAICS: 325413
New
SLED
Supply of INSTI® HIV-1/HIV-2 Test Controls (Product Code 90-1031)This subcontract involves the supply of specialized positive and negative control materials used to validate the performance of INSTI HIV-1/HIV-2 Antibody Tests for prime contractors working on New York City Department of Health and Mental Hygiene projects. The scope of work includes the preparation of positive controls from inactivated human plasma and negative controls from defibrinated human plasma, with a strict requirement that all positive controls be validated using U.S. FDA licensed test procedures. The contract, identified by product code 90-1031 and NAICS code 325413, focuses on the delivery of these validated control vials to be used within New York. The solicitation was posted on October 13, 2026, with a response deadline set for October 23, 2026.
Department Of Health And Mental Hygiene

POSTED

2 days ago

DEADLINE

in 8 days
View Details
NAICS: 325413
New
SLED
Supply of INSTI® HIV-1/HIV-2 Rapid Antibody Test KitsThis subcontract involves the supply of INSTI HIV-1/HIV-2 Rapid Antibody Test Kits to prime contractors supporting projects for the New York City Department of Health and Mental Hygiene. The contract focuses on providing complete, CLIA-waived rapid assay kits that utilize a flow-through immunofiltration design specifically engineered to detect anti-HIV-1 IgM antibodies within 21 days of infection. Each packaged point-of-care kit includes all necessary components for testing, such as membrane units, sample diluent, color developer, clarifying solution, alcohol swabs, lancets, and pipettes. The procurement is categorized under NAICS code 325413 and is designated for performance within New York City. Interested parties should note the response deadline of October 23, 2026, following the posting date of October 13, 2026. This agreement ensures that health projects managed by the city have access to specialized diagnostic tools for the rapid detection of HIV antibodies.
Department Of Health And Mental Hygiene

POSTED

2 days ago

DEADLINE

in 8 days
View Details
NAICS: 325413
New
SLED
81627Y0870-INSTI HIV-1/2 Test kits and INSTI Control Test kits
Solicitation # 81627Y0870
The New York City Department of Health and Mental Hygiene intends to enter into a six-year agreement with Biolytical Laboratories Inc. to provide INSTI HIV-1/HIV-2 Rapid Antibody Tests and corresponding Test Controls on an as-needed basis. These products will be utilized by the Bureau of HIV Field Services Unit and Sexually Transmitted Disease Clinics throughout New York City for the rapid detection of HIV antibodies. The agency has identified Biolytical Laboratories Inc. as the sole source provider and manufacturer, noting that there are no authorized resellers or distributors for these branded products. The required test kits are CLIA-waived rapid assays capable of providing results in as little as 60 seconds and feature a built-in IgG capture procedural control. Each kit includes membrane units, sample diluent, color developer, clarifying solution, and support materials such as alcohol swabs, lancets, and pipettes, with a shelf life of 15 months from the date of manufacture. Sites utilizing venipuncture whole blood or plasma must adhere to CLIA quality standards per 42 CFR Subparts H, J, K, and M. Interested firms capable of legally providing these goods must submit an Expression of Interest via the PASSPort portal for solicitation 81627Y0870 by October 23, 2026, at 2:00 PM.
Department Of Health And Mental Hygiene

POSTED

2 days ago

DEADLINE

in 8 days
View Details
NAICS: 325413
New
DIBBS
CONTROL, GLUCOSE
Solicitation # SPE2DS-27-T-0564
Solicitation SPE2DS-27-T-0564 is a fixed-price procurement issued by the DLA Troop Support Medical Supply Chain for one unit of Prodigy Blood Glucose Control Solution High Level 2 (NSN 6550-01-698-2104). This 4ML solution is used to ensure the accuracy of Prodigy blood glucose monitoring systems. The item must be delivered to PCU Arkansas SSN 800 in Hampton, Virginia, with a required delivery date of October 13, 2026, and a lead time of five days after receipt of order. The contract mandates strict quality and shelf-life requirements, specifying a non-extendable shelf life of 24 months, with no more than four months elapsed from the date of manufacture to the date of delivery. Storage must be maintained between 36 and 86 degrees Fahrenheit. Packaging must be commercial and sealed to prevent damage, adhering to RP001 and MIL-STD-2073-1E standards. All materials must be marked according to Medical Marking Standard No. 1, which supersedes MIL-STD-129, and labels must include the contract number, lot number, and relevant dates. Administrative compliance includes the use of the Wide Area Workflow system for invoicing and payment. The solicitation incorporates various FAR and DFARS clauses, including requirements for safeguarding covered defense information, adherence to the Buy American Act, and prohibitions on certain telecommunications equipment. Offerors must provide their CAGE code and specify the source and part number being supplied.
MEDICAL SUPPLY CHAIN MD SURG FSF

POSTED

3 days ago

DEADLINE

in 4 days
View Details

Win Contracts in In-Vitro Diagnostic Substance Manufacturing

Get AI-powered intelligence on NAICS 325413 procurement

Real-time contract opportunities for NAICS 325413 (In-Vitro Diagnostic Substance Manufacturing)

AI-powered matching based on your business capabilities and past performance

Competitive analysis of contractors winning awards in this industry

Automated alerts when new opportunities are posted

Miguel
Hillary
Keith Deutsch
Christine

Join 750+ contractors already using CLEATUS