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test to treat in one visit, with one sample, in 20 minutes or less
deliver results you can trust with gold-standard PCR technology
provide care when and where it's needed with a closed, compact system designed for CLIA-waived testing
SARS-CoV-2, Influenza A/B & RSV Assay*
SARS-CoV-2 & Influenza A/B
Influenza A/B & RSV
SARS-CoV-2
Strep A
Cdiff
*This product has not been FDA cleared or approved but has
been authorized for emergency use by FDA under an EUA for
use by authorized laboratories certified under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.
§263a, to perform high, moderate or waived complexity tests.
This product is authorized for use 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 and
differentiation of nucleic acid from SARS-CoV-2, influenza
A, influenza B, and RSV, not for any other viruses or
pathogens.
The emergency use of this product is only authorized for the
duration of the declaration that circumstances exist
justifying the authorization of emergency use of in vitro
diagnostics for detection and/or diagnosis of COVID-19 under
Section 564(b)(1) of the Federal Food, Drug and Cosmetic
Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is
terminated or authorization is revoked sooner.
**cobas® SARS-CoV-2 & Influenza A/B assay: If sample results
indicate co-infection of SARS-CoV-2 with Influenza A or
Influenza B and a positive influenza result would change
clinical management, the sample should be re-tested with a
second FDA cleared or EUA influenza test. cobas® SARS-CoV-2
assay: A negative result from an asymptomatic individual is
presumptive. See package insert for details.
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Indianapolis, IN 46256
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