LYME IGM ELISA TEST

FDA 510(k)

FDA Class 2 ·Microbiology

VERA

FDA 510(k)

FDA Class 2 ·Physical Medicine

GOLDEN MEAN MACHINE(TM) (CLASS 2)

FDA 510(k)

FDA Class 2 ·Physical Medicine

COBAS CT/NG V2.0 TEST

FDA 510(k)

FDA Class 2 ·Microbiology

GAMMA PHAGE LYSIS ASSAY FOR THE IDENTIFICATION OF BACILLUS ANTHRAC

FDA 510(k)

FDA Class 2 ·Microbiology

Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL

FDA 510(k)

FDA Class 2 ·Microbiology

BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP

FDA 510(k)

FDA Class 2 ·Microbiology

SLENDERTONE SYSTEM ULTRA MODEL E70/X70

FDA 510(k)

FDA Class 2 ·Physical Medicine

EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X

FDA 510(k)

FDA Class 2 ·Physical Medicine

HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE

FDA 510(k)

FDA Class 2 ·Microbiology

CELLOGNOST SYPHILIS H

FDA 510(k)

FDA Class 2 ·Microbiology

MERIFLUOR TM PNEUMOCYSTIS MODIFICATION

FDA 510(k)

FDA Class 2 ·Microbiology

Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology

BACTIGEN(R) N. MENINGITIDIS

FDA 510(k)

FDA Class 2 ·Microbiology

BIOFIRE FILMARRAY Gastrointestinal (GI) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

LIDO(TM) LIFT

FDA 510(k)

FDA Class 2 ·Physical Medicine

LOW AIR LOSS MATTRESS, MODIFICATION

FDA 510(k)

FDA Class 2 ·Physical Medicine

POWER DRIVE WHEELCHAIR

FDA 510(k)

FDA Class 2 ·Physical Medicine

PRECEPT METHICILLIN

FDA 510(k)

FDA Class 2 ·Microbiology