NAICS 325413 - In-Vitro Diagnostic Substance Manufacturing
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What is NAICS 325413
NAICS code 325413 covers establishments primarily engaged in manufacturing in-vitro diagnostic substances, which are chemical, biological, or radioactive materials used in diagnostic tests performed outside the human body. These substances are essential for laboratory testing devices such as test tubes, petri dishes, and automated diagnostic machines. Businesses operating in this sector include manufacturers specializing in reagents, assay kits, and diagnostic consumables that support clinical laboratories, research institutions, and healthcare providers. Government agencies contract these services to ensure a reliable supply of high-quality diagnostic substances crucial for public health monitoring, disease detection, and biosecurity measures. Reliable manufacturing of these substances supports timely diagnosis and treatment, which is vital for managing public health emergencies and ongoing medical research.
Industry Classification for NAICS 325413
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.
Breakdown for NAICS 325413
- Manufacturing of chemical, biological, or radioactive diagnostic substances used outside the human body.
- Includes products such as reagents, assay kits, and diagnostic consumables.
- Supports diagnostic tests performed in laboratory devices like test tubes and petri dishes.
- Typical small business size standard is based on employee count or revenue thresholds set by SBA.
- Contracts often require compliance with FDA regulations and quality standards.
- Critical to public health, biodefense, and clinical research initiatives.
Included Activities for NAICS 325413
- Producing chemical reagents for diagnostic assays.
- Manufacturing biological substances used in diagnostic testing.
- Formulating radioactive substances for diagnostic applications.
- Packaging and labeling in-vitro diagnostic test kits.
- Ensuring regulatory compliance and quality assurance for diagnostic products.
- Supplying diagnostic consumables to clinical laboratories and government health agencies.
- Custom developing diagnostic substances for specialized testing applications.
- Conducting stability and efficacy testing on manufactured diagnostic substances.
Business Types for NAICS 325413
- Specialized diagnostic reagent manufacturers.
- Biotechnology firms producing assay components.
- Contract manufacturing organizations (CMOs) for diagnostic substances.
- Small and medium-sized enterprises focused on in-vitro diagnostics.
- Laboratory supply companies with manufacturing capabilities.
- Research and development companies in diagnostic technology.
Subcategories for 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
Government Buyers for NAICS 325413
Federal agencies such as the Department of Health and Human Services (HHS), Centers for Disease Control and Prevention (CDC), Department of Defense (DoD), and Veterans Affairs (VA) commonly procure in-vitro diagnostic substances. These agencies require these products for clinical testing, disease surveillance, biodefense, and medical readiness programs. Additionally, state and local public health departments purchase these substances to support epidemiological testing and outbreak response. The demand from government buyers is driven by the need for accurate, validated, and compliant diagnostic products to inform health policies and protect populations from infectious diseases and other health threats.
Contract Types & Procurement for NAICS 325413
Contracts for NAICS 325413 typically include firm-fixed-price and indefinite-delivery/indefinite-quantity (IDIQ) contracts, reflecting the need for both one-time procurement and ongoing supply. Procurement methods often involve competitive bidding, sole-source contracts in urgent public health situations, and task orders under larger program contracts. Typical contract values can range from tens of thousands to several million dollars, depending on the volume and complexity of diagnostic substances required. Contracts may also include requirements for quality assurance, regulatory compliance, and delivery timelines critical to government health initiatives.
Details for NAICS 325413
Explore the hierarchy and related codes for this industry
| NAICS Code | Industry Title |
|---|---|
| 32541 | Pharmaceutical and Medicine Manufacturing |
| 3254 | Pharmaceutical and Medicine Manufacturing |
| 325 | Chemical Manufacturing |
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