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U.S. Department of Health and Human Services

Product Classification

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Device nucleic acid amplification test for the quantitation of epstein-barr virus (ebv) dna
Definition A quantitative viral nucleic acid test for transplant patient management is identified as a device intended for prescription use in the detection of viral pathogens by measurement of viral deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) using specified specimen processing, amplification, and detection instrumentation. The test is intended for use as an aid in the management of transplant patients with active viral infection or at risk for developing viral infections. The test results are intended to be interpreted by qualified healthcare professionals in conjunction with other relevant clinical and laboratory findings.
Physical State In vitro diagnostic test
Technical Method Quantitative Polymerase Chain Reaction
Target Area Blood and blood derived specimens
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeQLX
Premarket Review Division of Microbiology Devices (DMD)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3183
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible