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U.S. Department of Health and Human Services

Product Classification

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Device reagents, middle east respiratory syndrome corona virus (mers-co v) nucleic acid
Definition Nucleic acid-based in vitro diagnostic devices for the detection of middle east respiratory syndrome corona virus (mers-co v) 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 CodePOJ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
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
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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