Cue Health Cue, User Manual

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• The Cartridge Reader should be placed on a stable, flat,
and level surface while running a test. Do not move or tilt
the Reader while a test is in progress.
• This product has not been FDA cleared or approved.
• This product has been authorized by FDA under an
EUA for use by laboratories certified under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA),
42 U.S.C §263 a, to perform moderate complexity/high
complexity tests and at the Point of Care (POC), i.e., in
patient care settings operating under a CLIA Certificate
of Waiver, Certificate of Compliance, or Certificate of
Accreditation.
• This product has been authorized only for the detection
of nucleic acid from SARS CoV-2, not for any other
viruses or pathogens.
• This product 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 §3 60bbb-3(b)(1),
unless the authorization is terminated or revoked sooner.