«As a team, we are focused on meeting our customers' needs and keeping them for life.»



Quality Control

Products sold by Germaine® Laboratories, Inc. are manufactured under strict 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: 2003 and is applicable to the manufacture of In-Vitro diagnostic tests and reagents for professional, point of care, and self-test use for pregnancy, ovulation, urinalysis, drugs of abuse, serology, and strep 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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