FDA Facility

Germaine Laboratories, Inc. is a FDA registered facility that develops and supplies medical diagnostic tests for professional, point-of-care, and over-the-counter consumer use.

Germaine Laboratories, Inc. specialized services include:

  • Bulk and OEM packaging
  • Custom Labeling and Packaging
  • Custom Molded Cassettes
  • Regulatory consultation in FDA cGMP and ISO 13485:2003
  • Clinical Trials for Medical Devices and 510(k) Submissions

Our product line includes the brand names of AccuHome®, Aim™, AimScreen™, AimStep®, AimStrip®, AimTab™, Compliance Gold®, SafeCup™, and StrepAim.®  We specialize in rapid diagnostic tests and FDA approval.

OEM and private label inquiries are welcome.

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.

 

 

 

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