OEP — Influenza A Virus Subtype Differentiation Nucleic Acid Assay Class II

FDA Device Classification

Classification Details

Product Code
OEP
Device Class
Class II
Regulation Number
866.3980
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Definition

A qualitative in vitro diagnostic assay intended to detect and differentiate between influenza a virus subtypes in human respiratory specimens or viral culture. Detection and differentiation of specific subtype rna aids in the diagnosis of influenza caused by influenza a in conjunction with other clinical and laboratory testing in patients suspected of being infected with these viruses. Also, it aids in the presumptive laboratory identification of influenza a virus subtypes to provide epidemiological information on influenza.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K140851centers for disease control and preventionINFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTICApril 25, 2014