PathogenDx, Inc. Receives FDA Emergency Use Authorization for Microarray-based COVID-19 Test
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.
- Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.
- 263a, that meet requirements to perform high complexity tests.\nDetectX-Rv offers high-throughput capability and can process controls and 94 samples in a single run.\n"The entire PathogenDx team is committed to applying our deep knowledge of clinical diagnostics technology to develop accurate tests that can help contain the COVID-19 pandemic," said Milan Patel, Co-Founder and CEO of PathogenDx.\nThe FDA is responsible for regulating medical devices used to diagnose, prevent and treat COVID-19.
- 360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner.\nHeadquartered in Scottsdale, Arizona, PathogenDx\'s mission is to become the new standard in DNA-based testing through widespread adoption of its advanced microarray testing platform for the in vitro diagnostics, food and agricultural industries.
- For more information on how you can utilize this simple, powerful and inexpensive platform, visit www.pathogendx.com .\n'