Custom Manufacturing Center
Quality Microbial Growth and Preservation
We have extensive custom manufacture capabilities for bacteria/fungi, parasites, phage, and nucleic acids in virtually any form. Our versatile manufacturing capabilities allows us to design and produce customized solutions that alleviate your unique challenges.These bio-materials are available in a variety of formats, concentrations, strain combinations and applications. In addition, we also provide clinical isolates for your proficiency testing needs.
Learn more about our Lexington services:
Certifications and Registrations
ISO Certified and FDA Registered
We provide services and manufactured products in
accordance with a sound quality management system.
Registration with the FDA provides evidence that
Microbiologics adheres to all Current Good
Manufacturing Practices (CGMP.)
ISO 13485:2016 (Registration # MD19.8005, The National Standards Authority of Ireland (NSAI))
- Represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.
- The principal standard for manufacturers of medical products, devices and components.
- A testament to the manufacturer's quality management system and their ability to consistently design, develop, produce and distribute in-vitro microorganism preparations of the highest quality.
Food and Drug Administration Establishment (Registration #: 1050138)
- Applies to the facility, methods and controls used for the design, purchase, manufacture, packaging, labeling, storage and distribution of in-vitro medical diagnostic products.
- Ensures that finished products are safe, effective and in compliance with Federal Food and Drug and Cosmetic Act.