FDA Product Code QLX: Nucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna
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.
Leading manufacturers include Roche Molecular Systems, Inc..
List of Nucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Nucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna devices (product code QLX). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Microbiology FDA review panel. Browse all Microbiology devices →