CYTOMEGELISA M TEST KIT

FDA 510(k)

FDA Class 2 ·Microbiology

ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT

FDA 510(k)

FDA Class 2 ·Microbiology

SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

EPIDURAL CATHETER TRAY

FDA 510(k)

FDA Class 2 ·Microbiology

ACCURUN(TM) 130 BORRELIA BURGDORFERI IGG POSITIVE CONTROL

FDA 510(k)

FDA Class 2 ·Microbiology

MRSA/SA ELITE MGB, ELITE MGB SOFTWARE

FDA 510(k)

FDA Class 2 ·Microbiology

HAVAb IgG II

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert HCV; GeneXpert Xpress System

FDA 510(k)

FDA Class 2 ·Microbiology

WELLCOLEX COLOUR SALMONELLA TEST ZL 50

FDA 510(k)

FDA Class 2 ·Microbiology

SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES

FDA 510(k)

FDA Class 2 ·Microbiology

MERIFLUOR(TM) PNEUMOCYSTIS

FDA 510(k)

FDA Class 2 ·Microbiology

PASCO MIC AND MIC/ID PANELS

FDA 510(k)

FDA Class 2 ·Microbiology

MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANEL, B1017 PANEL SERIES

FDA 510(k)

FDA Class 2 ·Microbiology

PROSPEC T/GIARDIA RAPID ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

CMV BIO-BEAD SCREEN KIT

FDA 510(k)

FDA Class 2 ·Microbiology

REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS

FDA 510(k)

FDA Class 2 ·Microbiology

SERAQUEST TOXOPLASMA IGM

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO PASCO MIC AND MIC/ID PANELS (CLINDAMYCIN)

FDA 510(k)

FDA Class 2 ·Microbiology

The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL

FDA 510(k)

FDA Class 2 ·Microbiology