FilmArray Pneumonia Panel

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0

FDA 510(k)

FDA Class 2 ·Microbiology

BioFire Blood Culture Identification 2 (BCID2) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

SYPHILIS HEALTH CHECK

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Respiratory Panel (RP) for use with FilmArray Torch

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch

FDA 510(k)

FDA Class 2 ·Microbiology

Acucy® Influenza A&B Test with the Acucy® 2 System

FDA 510(k)

FDA Class 2 ·Microbiology

MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test

FDA 510(k)

FDA Class 2 ·Immunology

FilmArray Respiratory Panel EZ (RP EZ)

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Pneumonia Panel plus

FDA 510(k)

FDA Class 2 ·Pathology

VITEK REVEAL GN AST Assay and VITEK REVEAL AST System

FDA 510(k)

FDA Class 2 ·Microbiology

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO: BPCARD, MODEL Z-7000-0700

FDA 510(k)

FDA Class 2 ·Cardiovascular

EZ SMART

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Osom Ultra Plus Flu A&B Test Kit

FDA 510(k)

FDA Class 2 ·Microbiology

BioFire Joint Infection (JI) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Pneumonia Panel plus

FDA 510(k)

FDA Class 2 ·Pathology

FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch

FDA 510(k)

FDA Class 2 ·Microbiology

FETALTROL

FDA 510(k)

FDA Class 2 ·Hematology