QUANTA FLASH H-TTG IGA

FDA 510(k)

FDA Class 2 ·Immunology

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

MODIFICATION TO AESKULISA DS DNA G

FDA 510(k)

FDA Class 2 ·Immunology

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

HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE

FDA 510(k)

FDA Class 2 ·Microbiology

AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM

FDA 510(k)

FDA Class 2 ·Immunology

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

PRECEPT METHICILLIN

FDA 510(k)

FDA Class 2 ·Microbiology

ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST

FDA 510(k)

FDA Class 2 ·Immunology

Spectrum Saliva Collection Device

FDA 510(k)

FDA Class 2 ·Microbiology

ID NOW Influenza A & B 2

FDA 510(k)

FDA Class 2 ·Microbiology

QUANTA LITE MITOCHONDRIA M2 ELISA

FDA 510(k)

FDA Class 2 ·Immunology

VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL)

FDA 510(k)

FDA Class 2 ·Microbiology