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References

CA: CDF-90003755 | CLIA # 05D2220749 | CAP Accredited # 9512563

The UroAmp test has been developed, its performance characteristics determined, and validated by our CLIA-certified and CAP-accredited laboratory, which performs the test. The test has not been cleared or approved by the US Food and Drug Administration (FDA). Although FDA is exercising enforcement discretion of premarket review and other regulations for laboratory-developed tests in the US, certification of the laboratory is required under CLIA to ensure the quality and validity of the tests.