Licenses and Accreditations

At UTAK, we're committed to excellence, and we'll take every chance we have to prove it.
We currently hold the following certifications and licenses:

ISO 13485:2016
Medical Device Single Audit Program

Holding ourselves to the utmost standards for quality and consistency has been a part of UTAK’s culture since 1973. This certification is just another way that we demonstrate that commitment.

ISO 13485 is a voluntary international standard that lays out regulatory requirements for a quality management system designed to support medical device manufacturers. As makers of in vitro diagnostic devices, we have aligned UTAK’s internal processes with these international best practices to ensure consistency in design, development, manufacturing, and safety in our products.

View our ISO 13485:2016 certification.

ISO 9001:2015

ISO 9001 is an international standard that provides requirements for a quality management system focused on efficiently and effectively meeting customers’ needs. Our adherence to the guiding principles laid out in ISO 9001 demonstrates our passion for continuous improvement.

View our ISO 9001:2015 certification.

US Food & Drug Administration
Establishment Registration

UTAK is registered with the US Food & Drug Administration as a Medical Device Establishment.

View our registration, Number 2022375.

US Department of Justice; Drug Enforcement Agency; Controlled Substance Registration

For the purposes of handling the controlled substances present in many of our controls, we are registered as an Analytical Lab with the US Drug Enforcement Administration.

View our registration, Number PU0142808.

State of California, Food and Drug Branch; Device Manufacturing License

We are compliant with the state of California’s licensing requirements for Medical Device Manufacturers.

View our license, Number 62163.

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