DPP® Ebola Antigen System

A 15 minute rapid test for detection of Ebola Virus Specific Antigen

Granted An Emergency Use Authorization (EUA) by the U.S. FDA

Ebola Antigen System

Description

For the detection of antigen specific to Ebola Virus in fingerstick whole blood, EDTA venous whole blood and EDTA plasma.

Key features

  • Fast: Provides results in as little as 15 minutes
  • Convenient: Works with Fingerstick whole blood, Venous whole blood and Plasma
  • Easy to use: Provides objective results using simple, handheld digital reader (DPP® Micro Reader)
Product NameCatalog Number
DPP® Ebola Antigen System65-9545-0
DPP® Micro Reader for use with the DPP® Ebola Antigen System70-1057-0
DPP® Ebola Rapid Test Control Pack60-9554-0

*FDA Conditions for Authorization

  • This test has not been FDA cleared or approved
  • This test has been authorized by FDA under an EUA for use by authorized laboratories and facilities adequately equipped, trained and capable of testing for EVD (including treatment centers and public health clinics);
  • This test has been authorized only for the detection of Ebola virus, species Zaire ebolavirus, and any other Ebolavirus species if so authorized.
  • This test is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of Ebola virus under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
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