EZ-SARS-CoV-2 Real-Time RT-PCR Test

• For in vitro diagnostic use only. Rx only. For use under Emergency Use Authorization only.
• 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.
• This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, 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.

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Device: EZ-SARS-CoV-2 Real-Time RT-PCR
EUA Number: EUA202777
Company: Tetracore, Inc.
Indication: This test is authorized for the qualitative detection of nucleic acid
from SARS-CoV-2 in mid-turbinate nasal swab specimens from individuals suspected of COVID-19 by their healthcare provider.
Emergency use of this test is limited to authorized laboratories.
Authorized Laboratories: 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.


PLM-0618-5_IFU_EZ-SARS-CoV-2 Real-Time RT-PCR_13MAR2024 EUA202777 Tetracore_HCP FS 03-19-2024 EZ-SARS-CoV-2 Real-Time RT-PCR_Performance Characteristics_13MAR2024 EUA202777 Tetracore_PATIENT FS 03-19-2024

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