325413 - In-Vitro Diagnostic Substance Manufacturing
The NAICS code 325413 plays a crucial role in the healthcare and manufacturing landscape, specifically covering In-Vitro Diagnostic Substance Manufacturing. As the demand for advanced diagnostic testing grows, businesses under this code are at the forefront of developing essential reagents, test kits, and materials used in medical laboratories and healthcare settings worldwide.
What is NAICS Code 325413?
NAICS 325413 encompasses establishments primarily engaged in manufacturing in-vitro diagnostic substances. These substances include reagents, test kits, and other diagnostic materials utilized for testing biological samples outside the human body (in vitro). This industry supports crucial medical diagnostics by helping detect diseases, infections, and various medical conditions accurately and efficiently.
Sector and Core Business Activities
- Sector: Manufacturing
- Primary Activities:
- Manufacturing blood glucose test strips
- Production of pregnancy test kits
- Manufacturing diagnostic reagents for laboratory testing
- Producing substances for HIV, coagulation, hematology, and hormone testing
Companies in this sector help provide reliable testing solutions to medical professionals, hospitals, and diagnostic labs. The products are integral for quick, precise, and non-invasive health screening.
Size Standards for NAICS 325413 Eligibility
For government contracting and small business designations, the size standard for NAICS 325413 is set at:
- Maximum employees: 1,250 employees
Businesses having up to 1,250 employees may qualify as small businesses within this industry, which could help them access federal contracts, grants, and other business incentives.
Typical Business Types Under NAICS 325413
- Manufacturers of blood glucose test strips and kits
- Producers of pregnancy test kits and hormone detection kits
- Businesses engaged in the production of reagents and diagnostic substances for cytology, hematology, microbiology, and virology
- Companies specializing in HIV and viral test kits manufacturing
These activities showcase the diverse capabilities of companies operating under this NAICS code, all contributing significantly to the medical diagnostics supply chain.
Detailed Code Breakdown for NAICS 325413
| Code Detail | Description |
|---|---|
| Blood derivative in-vitro diagnostic substances | Manufacturing of diagnostic substances derived from blood |
| Blood glucose test kits manufacturing | Production of devices and reagents for glucose monitoring |
| Coagulation in-vitro diagnostic substances | Manufacturing materials used in blood clotting diagnostics |
| Cytology and histology in-vitro diagnostic substances | Production of substances for cellular and tissue diagnostics |
| Diagnostic substances, in-vitro | General production of diagnostic reagents and kits |
| Enzyme and isoenzyme in-vitro diagnostic substances | Manufacturing enzyme-based diagnostic substances |
| Hematology in-vitro diagnostic substances | Production of materials testing blood and its components |
| HIV test kits manufacturing | Manufacturing test kits for HIV detection |
| Hormone in-vitro diagnostic substances | Production of hormone detection diagnostic substances |
| In-vitro diagnostic substances manufacturing | Overall production of diagnostic substances for in-vitro use |
| Microbiology, virology, and serology in-vitro | Manufacturing diagnostic substances for infectious diseases |
| Pregnancy test kits manufacturing | Production of kits testing pregnancy through urine samples |
| Viral in-vitro diagnostic test substances | Manufacturing viral diagnostic test substances |
FAQs about NAICS Code 325413
What types of products are covered under NAICS 325413?
This code covers products such as in-vitro diagnostic reagents, test kits (including blood glucose and pregnancy tests), and other materials used for diagnostic testing outside the human body.
Which sector does NAICS 325413 belong to?
It falls under the Manufacturing sector.
What is the employee size standard for NAICS 325413 businesses?
Businesses with 1,250 employees or fewer are considered within the size standard limits.
Can a company manufacturing HIV test kits fall under NAICS 325413?
Yes, HIV test kits manufacturing is explicitly included in NAICS 325413.
Are enzyme-based diagnostic reagents part of this NAICS code?
Absolutely, enzyme and isoenzyme in-vitro diagnostic substances manufacturing falls within this code.
Conclusion
NAICS code 325413 - In-Vitro Diagnostic Substance Manufacturing represents a dynamic and essential manufacturing industry dedicated to producing diagnostic products critical for healthcare. From blood glucose test kits to advanced viral diagnostic reagents, companies operating under this code contribute to improving patient outcomes globally. For businesses targeting government contracts, understanding the size standards and scope of this NAICS code is vital.
Stay informed and explore opportunities in this vital manufacturing sector to help drive innovation in medical diagnostics.
Keywords: NAICS 325413, In-Vitro Diagnostic Substance Manufacturing, diagnostic test kits, blood glucose test strips manufacturing, pregnancy test kits, manufacturing diagnostics, HIV test kits, enzyme diagnostic substances, diagnostic reagents, manufacturing sector NAICS codes
