QDS — Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System Class II

FDA Device Classification

Classification Details

Product Code
QDS
Device Class
Class II
Regulation Number
866.4001
Submission Type
Review Panel
MI
Medical Specialty
Pathology
Implant
No

Definition

A Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and common respiratory pathogens qualitative, semi-quantitative or quantitative multiplex nucleic acid detection system is an in vitro diagnostic test for the detection, identification, and quantification of MERS-CoV and common respiratory pathogens – associated nucleic acids in human clinical specimens. The test is indicated for individuals meeting specific MERS-CoV clinical and/or epidemiological criteria. It aids in the differential diagnosis of MERS-CoV infection in conjunction with other clinical, epidemiologic, and laboratory data, in accordance with the guidelines provided by the appropriate public health authorities.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243222biofire diagnostics, llc (biomerieux)BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRANovember 6, 2024
K222601biofire diagnosticsFilmArray Pneumonia Panel plusOctober 27, 2022
K181324biofire diagnosticsFilmArray Pneumonia Panel plusNovember 15, 2018