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

Intended use
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.

Find out more about the current altona SARS-CoV-2 test kits reactivity analyses in response to mutations.

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.*.

Specifications

Sample types

Nasopharyngeal swabs
Oropharyngeal (throat) swabs
Anterior nasal swabs
Mid-turbinate nasal swabs
Nasal washes
Nasal aspirate

For use with

CFX96™ Touch Real-Time PCR Detection System
CFX96™ Touch Deep Well Real-Time PCR Detection System

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
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 e-mail address: support@altona-diagnostics.com

Order No

821025

Rxns

384

Transportation

Dry ice

Regulatory status

EUA

*Only available in the USA. For use under Emergency Use Authorization (EUA) only.

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

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