Regulatory Compliance
View our complete FDA registration documentation and CLIA waived certifications for rapid diagnostic tests. Proven Medical Testing maintains full compliance with all regulatory requirements for medical device distribution to healthcare providers.
FDA Establishment Registration
Our facility is registered with the FDA for the manufacture and distribution of over-the-counter diagnostic tests. Registration is renewed annually and verified through the FDA's public database.
CLIA-Waived Tests
Our rapid diagnostic tests meet the Clinical Laboratory Improvement Amendments (CLIA) requirements for waived tests, allowing their use in point-of-care and other healthcare settings with a CLIA Certificate of Waiver.
QC Approved
Our products have passed rigorous quality control checks, ensuring they meet the high standards required for quality control approval. This certification allows their use in diverse healthcare and diagnostic settings, confirming their reliability and precision.