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RealStar® SARS-CoV-2 RT-PCR Kit U.S.*

 

The RealStar® SARS-CoV-2 RT-PCR Kit U.S. is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal washes and nasal aspirates from individuals who are suspected of COVID-19 by their healthcare provider.

*only available in USA.   -  For Use Under Emergency Use Authorization (EUA) Only.

 

The RealStar® SARS-CoV-2 RT-PCR Kit U.S.* is authorized for a workflow consisting of nucleic acid extraction using the AltoStar® Automation System AM16 in combination with the AltoStar® Purification Kit 1.5 and the AltoStar® Internal Control 1.5, followed by the amplification and detection of SARS-CoV-2 specific RNA using the RealStar® SARS-CoV-2 RT-PCR Kit U.S.*.

Please remark:

  • This test has not been FDA-cleared or approved;
  • This test has been authorized by FDA under an EUA for use by authorized laboratories;
  • This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
  • This test is only authorized for the duration of declaration that circumstances exist justifying the authorization of the 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.

 

Any adverse events should be sent to the following Email adress: support@altona-diagnostics.com

 

RealStar® RealStar® SARS-CoV-2 RT-PCR Kit U.S.*

Order No.821025
Rxns384
Sample typesNasopharyngeal swabs
Oropharyngeal (throat) swabs
Anterior nasal swabs
Mid-turbinate nasal swabs
Nasal washes
Nasal aspirate
TransportationDry ice
For use withCFX96™ Touch Real-Time PCR Detection System
CFX96™ Touch Deep Well Real-Time PCR Detection System

RealStar® RealStar® SARS-CoV-2 RT-PCR Kit U.S.*

Instructions for use RealStar® SARS-CoV-2 RT-PCR Kit U.S.*

pdf
Release Date: 05/2020
Filesize: 703.78 KB

RealStar® RealStar® SARS-CoV-2 RT-PCR Kit U.S.*

Letter of Authorization (Date of EUA issuance 2020-04-22)

pdf
Release Date: 22.04.2020
Filesize: 252.90 KB

Fact Sheet for Health Care Providers (2020-04-22)

pdf
Release Date: 22.04.2020
Filesize: 240.92 KB

Fact Sheet for Patients (2020-04-22)

pdf
Release Date: 22.04.2020
Filesize: 211.74 KB