NAICS 325413

Overview

The North American Industry Classification System (NAICS) is the standard framework used by U.S. statistical agencies to group establishments for compiling and publishing economic data. Developed under the Office of Management and Budget with Canada and Mexico, NAICS replaced the SIC in 1997 and is updated every five years; the current vintage is 2022. ¹
U.S. Industry NAICS 325413 covers establishments primarily engaged in manufacturing in‑vitro (not taken internally) diagnostic substances—chemical, biological, or radioactive—used for tests performed in test tubes, petri dishes, machines, and other diagnostic test‑type devices. Federal data collections and many acquisition market analyses rely on this industry definition. ²

See also on G2X:

• G2X — NAICS 325413 overview
• G2X — NAICS 325414
• G2X — PSC 6550

What this NAICS covers

• Manufacturing chemical reagents intended for in‑vitro diagnostic testing (e.g., clinical chemistry, immunoassay applications). ²
• Producing biological diagnostic substances for in‑vitro use. ²
• Preparing radioactive diagnostic substances for in‑vitro assays. ²
• Making reagent kits or component substances used in test tubes, petri dishes, automated analyzers, and similar test devices. ²
• Supplying other in‑vitro diagnostic substances used within diagnostic test‑type devices and machines. ²

Related NAICS and PSC codes

Type	Code	Descriptor
NAICS	325412	Pharmaceutical Preparation Manufacturing (includes in‑vivo diagnostic substances)
NAICS	325414	Biological Product (except Diagnostic) Manufacturing
NAICS	334516	Analytical Laboratory Instrument Manufacturing
PSC	6550	In Vitro Diagnostic Substances, Reagents, Test Kits

Cross‑references and exclusions (official)

• In‑vivo diagnostic substances are classified in NAICS 325412, not in NAICS 325413. ²
• Vaccines, toxoids, blood fractions, and culture media of plant or animal origin (except diagnostic) belong in NAICS 325414. ²
• Manufacturing laboratory analyzers and instrumentation systems is covered by NAICS 334516, not by NAICS 325413. ²

Frequently asked questions

• What activities define NAICS 325413?
  Establishments primarily manufacture in‑vitro diagnostic substances—chemical, biological, or radioactive—used in tests performed in vessels, petri dishes, machines, and other diagnostic test‑type devices. ²

• How does NAICS 325413 differ from NAICS 325412 and NAICS 325414?
  NAICS 325413 covers in‑vitro diagnostic substances. NAICS 325412 covers pharmaceutical preparations and in‑vivo diagnostic substances; NAICS 325414 covers biological products except diagnostic. ²

• Are in‑vitro diagnostic reagents regulated as medical devices?
  FDA treats in vitro diagnostic products (inclusive of reagents, instruments, and systems) as medical devices, with labeling requirements in 21 CFR Part 809 and other device regulations. ³

• Do analyzers and instrumentation fall under NAICS 325413?
  No. Instruments and instrumentation systems for laboratory analysis are classified under NAICS 334516. ²

• Are complete test kits explicitly included in NAICS 325413?
  Official sources define the industry by manufacturing in‑vitro diagnostic substances; explicit treatment of complete kits is not specified. Not specified by official sources ².

Useful resources

• G2X — NAICS 325413 overview: https://app.g2xchange.com/naics/325413
• U.S. Census — Implementation of the 2022 NAICS vintage and timeline: https://www.census.gov/library/reference/code-lists/naics/2022/implementation-timeline.html
• U.S. Census — 2022 NAICS descriptions (NES reference files): https://www.census.gov/programs-surveys/nonemployer-statistics/technical-documentation/reference/naics-descriptions.html
• Acquisition.gov — Product and Service Codes (PSC) Manual (current edition): https://www.acquisition.gov/sites/default/files/manual/PSC%20Manual%20April%202025.pdf
• FDA — Overview of IVD regulation (including 21 CFR Part 809): https://www.fda.gov/medical-devices/ivd-regulatory-assistance/overview-ivd-regulation

References

1. U.S. Census Bureau — About Industry: update cadence and NAICS history (1997 adoption; 2022 update). https://www.census.gov/topics/employment/industry-occupation/about/industry.html
2. U.S. Census Bureau — 2022 NAICS Code 325413: In‑Vitro Diagnostic Substance Manufacturing (details and cross‑references). https://www.census.gov/naics/?input=325413&year=2022&details=325413
3. U.S. Food and Drug Administration — Overview of IVD regulation (includes 21 CFR Part 809). https://www.fda.gov/medical-devices/ivd-regulatory-assistance/overview-ivd-regulation