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Home / Products / RealStar / RealStar® MERS-CoV RT-PCR Kit U.S.*

RealStar® MERS-CoV RT-PCR Kit U.S.*

Intended use
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).

 

Specifications

Sample types

Tracheal aspirate
Tracheal secretions
Nasopharyngeal swabs

 

For use with

VERSANT® kPCR Molecular System AD (Siemens)
ABI Prism® 7500 SDS and 7500 Fast SDS (Applied Biosystems)
LightCycler® 480 Instrument II (Roche)
Rotor-Gene® 6000 (Corbett Research)
Rotor-Gene® Q 5/6 plex/MDx Platform (QIAGEN)
CFX96™ system/Dx real-time system (BIO-RAD)
CFX96 Touch™ Deep Well Real-Time PCR Detection System (BIO-RAD)

 

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

Order No
391022
Rxns
48
Transportation
Dry ice
Regulatory status
EUA

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

Manuals RealStar® MERS-CoV RT-PCR Kit U.S.*
Associated documents RealStar® MERS-CoV RT-PCR Kit U.S.*
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Manuals RealStar® MERS-CoV RT-PCR Kit U.S.*
Language
RealStar® MERS-CoV RT-PCR Kit U.S. - EN
Language: English
Date: 2020-05
Panel: Respiratory infections
Regulatory status: EUA
Associated documents RealStar® MERS-CoV RT-PCR Kit U.S.*
Language
Type of document
RealStar® MERS-CoV RT-PCR Kit U.S. - EN - 4
Language: English
Date: 2016-02-12
Panel: Respiratory infections
Regulatory status: EUA
RealStar® MERS-CoV RT-PCR Kit U.S. - EN - 2
Language: English
Date: 2016-02-12
Panel: Respiratory infections
Regulatory status: EUA
RealStar® MERS-CoV RT-PCR Kit U.S. - EN - 1
Language: English
Date: 2016-02-12
Panel: Respiratory infections
Regulatory status: EUA
RealStar® MERS-CoV RT-PCR Kit U.S. - EN - 3
Language: English
Date: 2016-02-12
Panel: Respiratory infections
Regulatory status: EUA