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U.S. Department of Health and Human Services

Product Classification
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Device reagents, ebola zaire virus (detected in the west africa outbreak in 2014) nucleic acid
Definition Nucleic acid-based in vitro diagnostic devices for the presumptive detection and identification of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in human clinical specimens
Physical State In Vitro Diagnostic Primers and Probes
Technical Method Nucleic acid amplification
Target Area The device is an in-vitro diagnostic device; none of the body parts will utilize the device or are intended to be affected by the device
Review Panel Microbiology
Product CodePOG
Premarket Review Division of Microbiology Devices (DMD)
Division of Microbiology Devices (DMD)
Not Classified Reason EUA - Emergency Use Authorization
Submission Type EUA - Emergency Use Authorization
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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