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The tests described have been developed and their performance characteristics
determined by the CLIA-certified laboratory performing the test. The tests have
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. CAP accredited, ISO 13485 certified, and CLIA certified. © 2023 Natera,
Inc. All Rights Reserved.


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