Clinical Reference Laboratory is one of the largest privately held clinical testing laboratories in the U.S., performing hundreds of thousands of tests every day. Our staff of more than 700 associates works around-the-clock to process and report results seven days a week for many of the largest retail, transportation, pharmaceutical, healthcare, and financial service organizations in the world.
This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by Clinical Reference Laboratory, Inc. located in Lenexa, KS. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
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