NAICS UNIVERSITY · Free research for insurance agents
In-Vitro Diagnostic Substance Manufacturing
NAICS 325413 · United States · 2022 edition
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.
Start with the work promised to the client.
For In-Vitro Diagnostic Substance Manufacturing, clarify the services, contracts and consequences of an error. Review products liability, recall and contamination, premises and employee exposure. Confirm which professional activities and additional services the proposed coverage actually addresses.
Questions to ask
- What specific product categories are manufactured — reagents, assay kits, calibrators, controls — and what diagnostic applications do they serve?
- What is the current FDA regulatory status — 510(k) cleared, PMA, listed, or exempt — and are there any open enforcement actions or warning letters?
- Does the operation involve biological, radioactive, or select-agent materials, and what containment and disposal protocols are in place?
- What is the scope of distribution — domestic only, international, direct to labs, through distributors, or OEM supply to device manufacturers?
- Has the company experienced any product recalls, field corrections, or customer notifications in the past five years?
- Are any technical consulting, custom assay development, or laboratory services provided alongside product sales?
- For In-Vitro Diagnostic Substance Manufacturing, what should the underwriter know about active fda warning letters, consent decrees, or class i recall history?
- For In-Vitro Diagnostic Substance Manufacturing, what should the underwriter know about products used in high-severity diagnostic categories such as oncology, infectious disease, or critical-care markers where misdiagnosis claims carry extreme patient-harm potential?
Activities described by this code
Other activities to examine
Census classification reference
For educational purposes only. AI-generated insurance research and automated logic can contain errors. Independently verify classification and coverage decisions.
Compare another operationInsurance operations research — draft
In-vitro diagnostic substance manufacturers produce chemical, biological, or radioactive substances used in diagnostic testing performed outside the human body — in laboratory instruments, test tubes, petri dishes, or point-of-care devices. Day-to-day operations typically include formulation, quality control, regulatory compliance, and distribution of reagents, assay kits, calibrators, or controls to clinical laboratories, hospitals, or medical device manufacturers. FDA oversight under 21 CFR Part 820 and related regulations is a routine operational reality for most establishments in this class.
Questions to investigate
- What specific product categories are manufactured — reagents, assay kits, calibrators, controls — and what diagnostic applications do they serve?
- What is the current FDA regulatory status — 510(k) cleared, PMA, listed, or exempt — and are there any open enforcement actions or warning letters?
- Does the operation involve biological, radioactive, or select-agent materials, and what containment and disposal protocols are in place?
- What is the scope of distribution — domestic only, international, direct to labs, through distributors, or OEM supply to device manufacturers?
This insurance research was generated in April 2026. It has not received a complete human review. The October 12, 2026 audit checked codes and titles only, not descriptions or coverage assertions.