ARUP provides reference laboratory testing for hospitals and health centers, serving the diagnostic needs of patients. We also consult on lab management, utilization, and operations.

Under the FDA rule, New York approval still means that, but it also means labs can avoid submitting a test to the FDA for premarket notification or approval. It is a faster and much less …

Mar 31, 2025 · The company has a robust quality management system and has experience working with the New York Clinical Laboratory Evaluation Program (CLEP) for test approval. …

Testing Specialties This page highlights our testing specialties, test updates, testing resources, compliance statements, and experts.

New York DOH Approval Status Indicates whether a test has been approved by the New York State Department of Health.

Aug 19, 2025 · Our latest white paper, “Navigating AI in the Clinical Laboratory: Key Considerations,” provides a thorough exploration of the benefits and challenges of adopting …

ARUP Laboratories ARUP is a nonprofit clinical laboratory enterprise of the University of Utah Department of Pathology

Approval to submit specimens to laboratories that do not hold New York State permits or test-specific Department approval will be granted if the requests to conduct the test are limited in …

Mar 17, 2025 · FDA Regulation of In Vitro Diagnostics NYS CLEP [New York State Clinical Laboratory Evaluation Program] and LDTs Discussion The FDA Regulation of In Vitro …

A Federal Court Judge Vacated in Its Entirety the FDA’s Final Rule on Lab-Developed Tests The rule and its compliance deadlines are no longer in effect, benefiting patient care, innovation, …