GERMAINE LABORATORIES, INC

All products produced by Germaine® Laboratories, Inc. are manufactured under strict quality control through cGMP (Good Manufacturing Practices) as overseen by the FDA. Our facility has also been approved to the Quality Management System Standards of ISO 13485: 2016 which is applicable to the manufacturing and distribution of In Vitro Diagnostic Tests, In Vitro Diagnostic Analyzers, and Reagents for Professional, Point of Care, and Self-Test Use used 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.