cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Respiratory Panel 2 plus (RP2plus)

FDA 510(k)

FDA Class 2 ·Pathology

BOBCAT DX

FDA 510(k)

FDA Class 2 ·Physical Medicine

DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC

FDA 510(k)

FDA Class 2 ·Anesthesiology

Cue COVID-19 Molecular Test

FDA 510(k)

FDA Class 2 ·Microbiology

Cue COVID-19 Molecular Test

FDA 510(k)

FDA Class 2 ·Microbiology

BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini

FDA 510(k)

FDA Class 2 ·Microbiology

BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

QIAstat-Dx® Respiratory Panel Plus

FDA 510(k)

FDA Class 2 ·Microbiology

Visby Medical Respiratory Health Test

FDA 510(k)

FDA Class 2 ·Microbiology

BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini

FDA 510(k)

FDA Class 2 ·Microbiology

BioFire Respiratory Panel 2.1 (RP2.1)

FDA 510(k)

FDA Class 2 ·Microbiology

Simplexa COVID-19 & Flu A/B Direct

FDA 510(k)

FDA Class 2 ·Microbiology

BIOFIRE SPOTFIRE Respiratory (R) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

Alinity m Resp-4-Plex

FDA 510(k)

FDA Class 2 ·Microbiology

NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)

FDA 510(k)

FDA Class 2 ·Microbiology

QIAstat-Dx Respiratory Panel Mini

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Pneumonia Panel plus

FDA 510(k)

FDA Class 2 ·Pathology

BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)

FDA 510(k)

FDA Class 2 ·Pathology

LIAISON PLEX Respiratory Flex Assay

FDA 510(k)

FDA Class 2 ·Microbiology