FDA Product Code OOU: Parainfluenza Multiplex Nucleic Acid Assay
A Parainfluenza Multiplex Nucleic Acid Assay Is A Multiplex In Vitro Diagnostic Test For The Simultaneous Qualitative Detection And Discrimination Of Parainfluenza 1 Virus, Parainfluenza 2 Virus, Parainfluenza 3 Virus And Parainfluenza 4 Virus Nucleic Acids Isolated And Purified From Human Respiratory Specimens Obtained From Individuals Exhibiting Signs And Symptoms Of Respiratory Tract Infections Or Viral Culture. The Detection And Discrimination Of Human Parainfluenza Nucleic Acids From Symptomatic Patients Aid In The Diagnosis Of Human Respiratory Tract Parainfluenza Infections If Used In Conjunction With Other Clinical And Laboratory Findings.
Leading manufacturers include Hologic, Inc..
5
Total
5
Cleared
93d
Avg days
2009
Since
FDA 510(k) Cleared Parainfluenza Multiplex Nucleic Acid Assay Devices (Product Code OOU)
5 devices
Cleared
Oct 23, 2017
Panther Fusion Paraflu Assay
Hologic, Inc.
Microbiology
87d
Cleared
Dec 09, 2015
ProParaFlu+ Assay
Hologic, Inc.
Microbiology
33d