Standard
Phone
Tablet
Desktop
Large Desktop
Very Large Desktop
---

RealStar® Ebolavirus RT-PCR Kit 1.0*

 

The RealStar® Ebolavirus RT-PCR Kit 1.0* is for the presumptive detection of RNA from Ebolavirus (including Zaire ebolavirus detected in the West Africa outbreak in 2014) on specified instruments in EDTA plasma specimens from individuals with signs and symptoms of Ebolavirus infection in conjunction with epidemiological risk factors.

 

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

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 RNA from Ebolavirus (such as Zaire ebolavirus (including Zaire ebolavirus strain detected in the West Africa outbreak in 2014),Sudan ebolavirus, Tai Forest ebolavirus, Bundibugyo ebolavirus and Reston ebolavirus) and not for any other viruses or pathogens; 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 Zaire ebolavirus under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
  • The RealStar® Ebolavirus RT-PCR Kit 1.0* is ready-to-use and compatible with various real-time PCR platforms.

 

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

 

RealStar® Ebolavirus RT-PCR Kit 1.0*

Order No.581023
Rxns96
Sample typesHuman EDTA plasma
TransportationDry ice
For use withABI Prism® 7500 SDS and 7500 Fast SDS
LightCycler® 480 Instrument II
CFX96™ Real-Time PCR Detection System

Related Product:

 

The RealStar® Ebolavirus Quantification Panel 1.0 is a five member verification and validation Panel representing three different concentrations (low, middle and high) of an in-vitro transcript (IVT) comprising the target sequence of the RealStar® Ebolavirus RT-PCR Kit 1.0. It can be used for the verfication and validation of the RealStar® Ebolavirus RT-PCR KIt 1.0.

The RealStar® Ebolavirus Quantification Panel 1.0 is for research use only and not for use in diagnostic procedures.


RealStar® Ebolavirus Quantification Panel 1.0

Order No.5810QP
Components10 x 140 μl
TransportationDry ice
For use withQIAamp® Viral RNA Mini Kit

RealStar® Ebolavirus RT-PCR Kit 1.0*

Instructions for use RealStar® Ebolavirus RT-PCR Kit 1.0*

pdf
Release Date: 19.10.2018
Filesize: 997.30 KB

RealStar® Ebolavirus RT-PCR Kit 1.0*

Letter of Authorization (Date of EUA issuance 2014-11-26)6)

pdf
Release Date: 26.11.2014
Filesize: 1.23 MB

Fact Sheet for Health Care Providers

pdf
Release Date: 12.02.2016
Filesize: 1.29 MB

Fact Sheet for Patients

pdf
Release Date: 12.02.2016
Filesize: 915.30 KB

RealStar ® Ebolavirus Qualification Panel 1.0

pdf
Release Date: 02/2015
Filesize: 259.78 KB