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

BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Pneumonia Panel plus

FDA 510(k)

FDA Class 2 ·Pathology

Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel

FDA 510(k)

FDA Class 2 ·Microbiology

Radioimmunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·CYCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS

Radioimmunoassay For Cyclosporine

FDA Pre-Market Approval

FDA Class 2 ·1YCLO-TRAC SP WHOLE BLOOD & SERUM/PLASMA ASSAYS

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

ID NOW COVID-19 2.0

FDA 510(k)

FDA Class 2 ·Microbiology

Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set

FDA 510(k)

FDA Class 2 ·Microbiology

BinaxNOW COVID-19 Ag Card

FDA 510(k)

FDA Class 2 ·Microbiology

SCoV-2 Ag Detect Rapid Test

FDA 510(k)

FDA Class 2 ·Microbiology

Healgen Rapid COVID-19 Antigen Test

FDA 510(k)

FDA Class 2 ·Microbiology

Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set

FDA 510(k)

FDA Class 2 ·Microbiology