FilmArray 2.0 System

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Acucy Influenza A&B Test with the Acucy System

FDA 510(k)

FDA Class 2 ·Microbiology

SENSAIRE DIAGNOSTIC SPIROMETER

FDA 510(k)

FDA Class 2 ·Anesthesiology

VasoGuard (V10, V8, V6, V4, V2)

FDA 510(k)

FDA Class 2 ·Cardiovascular

FilmArray Meningitis/Encephalitis(ME) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

SPIROCARD

FDA 510(k)

FDA Class 2 ·Anesthesiology

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

FDA 510(k)

FDA Class 2 ·Microbiology

EKGCARD SYSTEM

FDA 510(k)

FDA Class 2 ·Cardiovascular

FilmArray Respiratory Panel 2 (RP2)

FDA 510(k)

FDA Class 2 ·Microbiology

SAM Model 9-10000

FDA 510(k)

FDA Class 2 ·Anesthesiology

INSTACCULT

FDA 510(k)

FDA Class 2 ·Hematology

FilmArray Blood Culture Identification (BCID) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))

FDA 510(k)

FDA Class 2 ·Microbiology

BioFire Respiratory Panel 2.1 (RP2.1)

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0

FDA 510(k)

FDA Class 2 ·Microbiology

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