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RealStar® MERS-CoV RT-PCR Kit U.S.*

 

The RealStar® MERS-CoV RT-PCR Kit U.S.* is a real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of RNA from Middle East respiratory syndrome coronavirus (MERS-CoV).

Sample Types

  • in lower respiratory samples (tracheal aspirate / tracheal secretions) from patients with signs and symptoms of Middle East respiratory syndrome coronavirus infection in conjunction with epidemiological risk factors.
  • in nasopharyngeal swabs from asymptomatic individuals suspected of exposure to MERS-CoV cases based on epidemiological risk factors (e.g., contact with a probable or confirmed MERS-CoV case, history of travel to geographic locations where MERS-CoV cases were detected, or other epidemiologic links for which MERS-CoV testing may be indicated).

Please remark:

  • This test has not been FDA-cleared or approved;
  • This test has been authorized by FDA under an EUA for use by CLIA High Complexity Laboratories and similarly qualified non-U.S. laboratories;
  • This test has been authorized only for the detection of MERS-CoV; and
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of MERS-CoV 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® MERS-CoV RT-PCR Kit U.S.*

Order No.391022
Rxns48
Sample typesLower respiratory samples (tracheal aspirate / tracheal secretions)
Nasopharyngeal swabs
TransportationDry ice
For use withVERSANT® kPCR Molecular System AD
ABI Prism® 7500 SDS and 7500 Fast SDS
LightCycler® 480 Instrument II
Roto-Gene® 6000
Rotor-Gene® Q 5/6 plex Platfom
CFX96™ Real-Time PCR Detection System and
CFX96™ Deep Well Real-Time PCR Detection System

RealStar® MERS-CoV RT-PCR Kit U.S.*

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

pdf
Release Date: 05/2020
Filesize: 2.04 MB

RealStar® MERS-CoV RT-PCR Kit U.S.*

Letter of Authorization (Date of EUA issuance 2016-02-12)

pdf
Release Date: 12.02.2016
Filesize: 1.44 MB

Fact Sheet for Asymptomatic Individuals

pdf
Release Date: 12.02.2016
Filesize: 1.05 MB

Fact Sheet for Health Care Providers

pdf
Release Date: 12.02.2016
Filesize: 1.72 MB

Fact Sheet for Patients

pdf
Release Date: 12.02.2016
Filesize: 1.06 MB