«The SafeCup™ is designed to eliminate the collectors exposure to the urine specimen.»



History

MISSION STATEMENT

Quality In Everything We Do!  Through our actions, we earn the trust of our customers and team members. As a team, we are focused on meeting our customers' needs and keeping them for life.  We believe continuous learning improves our contributions. Our work creates profit for our company and opportunity for us by creating quality and value for our customers.

ESTABLISHED

Founded in 1990 in San Antonio, Texas, the company incorporated and became Germaine® Laboratories, Inc. in 1997. That same year was also a landmark year in the growth of the Germaine® Laboratories, Inc., when we completed our initial clinical trials for the AccuHome® urine pregnancy test and received our first 510(k) clearance from the Food & Drug Administration (FDA). Over the past 19 years our product lines have grown to include diagnostic tests for pregnancy, drugs of abuse, febrile antigens, fecal occult blood, H. pylori, ovulation, pork testing, serology, strep A and urinalysis. Our product line includes the brand names AccuHome®, Aim™, AimScreen™, AimStep®, AimStrip®, Compliance Gold®, CellFix™, SafeCup™ and StrepAim®.

QUALITY PRODUCTS

All products sold 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 13485:2003 and is applicable to the manufacture of In-Vitro diagnostic tests and reagents for professional, point of care, and self-test use for pregnancy, infectious disease, hematology, ovulation, fecal occult blood, drugs of abuse, serology, strep a, and urinalysis products.

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

ADMINISTRATION

The management staff of our Drugs of Abuse Testing division has many years experience working in the industry and implementing programs with major employers, School Districts, Criminal Justice and Drug Court entities throughout the United States. This experience encompasses the development of drug testing programs and conversion to non-instrumented immunoassay screening.

DRUG TESTING LABORATORY

Our contracted laboratory is designed to be the nation’s most advanced drug-testing laboratory in the industry. The lab utilizes the latest technology including high throughput drug screening instruments and highly efficient specimen processing systems.  Turn-around-times on results exceed the accepted industry standard. Over 80% of the negative screens are reported by 8:00 a.m. CT, the day after collection. All negative results are reported by 1:00 p.m. CT. In addition, the laboratory employs technical management personnel with over 20 years of experience in substance abuse testing.

Our contracted laboratory currently performs over 6,500 drug-screening tests per day. In addition, the lab performs more than 500 GC/MS confirmations per day. Our contracted laboratory was granted SAMHSA certification, by the Department of Health and Human Services, on March 26, 1999. The laboratory maintains this certification and is re-inspected semi-annually to insure all processes and procedures are performed properly. The laboratory also holds all the necessary state licenses and accreditations. In addition, the laboratory employs technical management personnel with over twenty years of experience in substance abuse testing.

SERVICE

Germaine® Laboratories, Inc. has provided immunoassay tests to clients throughout the world.  We have the proven ability to meet the needs of your organization, in quality of product, delivery of ordered quantities, and the development of custom products and drug testing panels for specific needs.

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