«"The tests you want. The accuracy you need"»

Quality Control

Products sold by Germaine® Laboratories, Inc. are manufactured under strict control through cGMP (Good Manufacturing Practices).

Our facility has also been approved to the Quality Management System Standards of ISO 13485: 2016 and is applicable to the manufacture of In-Vitro diagnostic tests, In Vitro Diagnostic Analyzers, and reagents for Professional, Point of care, and self-test use in the diagnosis, management, disease status and detection of Blood Glucose Monitoring, Clinical Chemistry, Drug of Abuse, Hematology, Infectious Diseases, Pregnancy/Fertility, Serology, and Urinalysis products.

These certifications attest to the quality standards set and achieved for the manufacture of the entire Germaine® Laboratories product line.

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