Passion For Quality

Quality Policy Statement

EntroGen, Inc. undertakes to comply with applicable regulatory requirements on its products and commits to provide customers with quality products and supports that meet or exceed their requirements and expectations.  By maintaining and continuously improving business processes we will enhance the value of our company to our customers.

More than

Kits Manufactured

More than

Patient Samples Tested

More than

Adverse Events Reported

More than

%

QC Release Compliance

Less than

Hour technical support inquiry turnaround time

Products shipped to

Countries around the world

FDA Approved Manufacturing Facility / cGMP

FDA Establishment Registration Number: 3010791816
Owner/Operator Number: 10088140

 

ISO 13485 Certified Quality Management System

 

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