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Quality

Lincoln Diagnostics is committed to producing the highest-quality products for customers around the world.

Commitment to Quality

We are fully committed to producing allergy skin testing devices of the highest quality and effectiveness that meet or exceed customer requirements. To maintain this total commitment to quality, we've put procedures, controls, and processes in place that ensure the manufacture of high-quality products.

Certification

In addition to adhering to current FDA Good Manufacturing Practices, Lincoln Diagnostics holds the following certifications:

  • ISO 13485 certified in the design and manufacture of disposable allergy skin test devices.
  • MDSAP certified in compliance with US FDA, Health Canada, Brazil ANVISA, and Australia TGA medical devices regulations.