Welcome to a New Era in Detection EUA Granted for Antigen Test EU t Circulating Variants Detected Ci d 3- 3-Simple Steps to Results
BIOTECHNOLOGIES
Qorvo Biotechnologies brings a unique approach to the health diagnostics testing landscape. Using Bulk Acoustic Wave (BAW) technology, the Qorvo Omnia is designed to deliver rapid results for SARS-CoV-2 antigen testing.
TM Antigen Test*
Low limit of SARS-CoV-2 detection
100% Specificity STEP 1 Add sample STEP 2 Insert Cartridge STEP 3 Report Results
IN DEVELOPMENT, NOT AVAILABLE FOR SALE IN THE US: SARS-CoV-2 IgG antibody test
SARS-CoV-2/Flu A & B combo test
*This product has not been FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; and the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use 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. These statements reflect the data submitted to the FDA under the EUA process.
Qualified using nasal swabs
platform
© 10-2021 Qorvo US, Inc. | QORVO BIOTECHNOLOGIES and OMNIA are trademarks of Qorvo US, Inc.
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