NAICS Code 325412-13 - Allergy Laboratories (Manufacturing)

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NAICS Code 325412-13 Description (8-Digit)

Allergy Laboratories (Manufacturing) is a subdivision of the Pharmaceutical Preparation Manufacturing industry that specializes in the production of diagnostic and therapeutic products for the treatment of allergies. This industry involves the manufacturing of allergen extracts, which are used to diagnose and treat allergies, as well as immunotherapy products, which are used to desensitize patients to allergens. Allergy Laboratories (Manufacturing) also produces allergy testing kits, which are used by healthcare professionals to diagnose allergies in patients. The manufacturing process for Allergy Laboratories (Manufacturing) involves the extraction of allergens from various sources, such as pollen, dust, and animal dander. These allergens are then purified and standardized to ensure consistent potency and quality. The purified allergens are then used to create allergen extracts, which are formulated into diagnostic and therapeutic products. Allergy Laboratories (Manufacturing) plays a crucial role in the healthcare industry by providing healthcare professionals with the tools they need to diagnose and treat allergies. Allergy testing and immunotherapy are important components of allergy treatment, and Allergy Laboratories (Manufacturing) provides the products necessary to carry out these procedures.

Hierarchy Navigation for NAICS Code 325412-13

Tools

Tools commonly used in the Allergy Laboratories (Manufacturing) industry for day-to-day tasks and operations.

  • Allergen extractors
  • Purification systems
  • Standardization equipment
  • Formulation equipment
  • Filling machines
  • Labeling machines
  • Packaging equipment
  • Quality control instruments
  • Microscopes
  • Centrifuges
  • Incubators
  • Refrigerators
  • Freezers
  • Pipettes
  • Test tubes
  • Petri dishes
  • Microtomes
  • Spectrophotometers
  • Chromatography equipment

Industry Examples of Allergy Laboratories (Manufacturing)

Common products and services typical of NAICS Code 325412-13, illustrating the main business activities and contributions to the market.

  • Allergy testing kits
  • Immunotherapy products
  • Allergen extracts
  • Allergy diagnostic products
  • Allergy treatment products
  • Allergy desensitization products
  • Allergy immunotherapy products
  • Allergy skin testing products
  • Allergy blood testing products
  • Allergy serums

Certifications, Compliance and Licenses for NAICS Code 325412-13 - Allergy Laboratories (Manufacturing)

The specific certifications, permits, licenses, and regulatory compliance requirements within the United States for this industry.

  • Good Manufacturing Practice (GMP): GMP is a set of regulations enforced by the FDA to ensure that pharmaceutical products are consistently produced and controlled according to quality standards. Allergy Laboratories (Manufacturing) must comply with GMP regulations to ensure the safety and efficacy of their products. The FDA provides GMP certification.
  • ISO 13485: ISO 13485 is an international standard that specifies requirements for a quality management system specific to the medical device industry. Allergy Laboratories (Manufacturing) can obtain ISO 13485 certification to demonstrate their commitment to quality management. The International Organization for Standardization (ISO) provides ISO 13485 certification.
  • Occupational Safety and Health Administration (OSHA) Hazard Communication Standard: The OSHA Hazard Communication Standard requires employers to provide information and training to employees about hazardous chemicals in the workplace. Allergy Laboratories (Manufacturing) must comply with this standard to ensure the safety of their employees. The OSHA provides certification for compliance with this standard.
  • Environmental Protection Agency (EPA) Toxic Substances Control Act (TSCA) Certification: The TSCA requires manufacturers to report and maintain records on chemicals they produce or import. Allergy Laboratories (Manufacturing) must comply with TSCA regulations to ensure the safety of their products. The EPA provides TSCA certification.
  • National Institute for Occupational Safety and Health (NIOSH) Certification: NIOSH is a federal agency that conducts research and makes recommendations to prevent work-related injuries and illnesses. Allergy Laboratories (Manufacturing) can obtain NIOSH certification for their respiratory protective devices to ensure their effectiveness. The Centers for Disease Control and Prevention (CDC) provides NIOSH certification.

History

A concise historical narrative of NAICS Code 325412-13 covering global milestones and recent developments within the United States.

  • The "Allergy Laboratories (Manufacturing)" industry has a long history of providing allergy testing and treatment solutions to patients worldwide. The first allergy test was developed in 1906 by Leonard Noon and John Freeman, which involved injecting small amounts of allergens into the skin to observe the reaction. In the 1920s, the first allergy serum was developed by Alk-Abello, which was used to treat hay fever. In the 1950s, the first antihistamine medication was introduced, which revolutionized allergy treatment. In recent years, the industry has seen advancements in immunotherapy, which involves exposing patients to small amounts of allergens to build up their immunity. The use of sublingual immunotherapy has also gained popularity, which involves placing a tablet containing allergens under the tongue to treat allergies. In the United States, the "Allergy Laboratories (Manufacturing)" industry has seen significant growth in recent years due to the increasing prevalence of allergies. According to the Asthma and Allergy Foundation of America, allergies affect more than 50 million Americans each year. The industry has seen advancements in allergy testing, including the use of blood tests to detect allergens. The development of new allergy medications, such as biologics, has also contributed to the growth of the industry. Overall, the industry has a bright future as the demand for allergy testing and treatment solutions continues to increase.

Future Outlook for Allergy Laboratories (Manufacturing)

The anticipated future trajectory of the NAICS 325412-13 industry in the USA, offering insights into potential trends, innovations, and challenges expected to shape its landscape.

  • Growth Prediction: Growing

    The future outlook for the Allergy Laboratories (Manufacturing) industry in the USA is positive. The increasing prevalence of allergies and the growing demand for allergy testing and treatment are expected to drive the growth of the industry. Additionally, the rising awareness of allergies and the availability of advanced diagnostic tools are expected to boost the demand for allergy testing. The industry is also expected to benefit from the increasing investment in research and development activities to develop new and effective allergy treatments. However, the industry may face challenges such as the high cost of allergy testing and treatment and the shortage of skilled professionals in the field.

Industry Innovations for NAICS Code 325412-13

Recent groundbreaking advancements and milestones in the Allergy Laboratories (Manufacturing) industry, reflecting notable innovations that have reshaped its landscape.

  • Development Of New Allergy Treatments: The industry has witnessed the development of new allergy treatments such as sublingual immunotherapy and oral immunotherapy, which have shown promising results in treating allergies.
  • Advanced Diagnostic Tools: The industry has seen the development of advanced diagnostic tools such as skin prick tests, blood tests, and patch tests, which have improved the accuracy of allergy diagnosis.
  • Allergy Immunotherapy Tablets: The industry has witnessed the development of allergy immunotherapy tablets, which are a convenient and effective alternative to allergy shots.
  • Telemedicine Services: The industry has seen the adoption of telemedicine services, which have made it easier for patients to access allergy testing and treatment from the comfort of their homes.
  • Personalized Allergy Treatment: The industry has witnessed the development of personalized allergy treatment, which involves identifying the specific allergens that trigger an individual's allergies and developing a customized treatment plan.

NAICS Code 325412-13 - Allergy Laboratories (Manufacturing)

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