Xpert MRSA/SA SSTI

FDA 510(k)

FDA Class 2 ·Microbiology

BD MAX MRSA ASSAY, BD MAX INSTRUMENT

FDA 510(k)

FDA Class 2 ·Microbiology

IDI-MRSA ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

ARIES MRSA Assay

FDA 510(k)

FDA Class 2 ·Microbiology

XPERT MRSA/SA BLOOD CULTURE ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

BD GENEOHM MRSA ACP ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

BD MAX MRSA XT, BD MAX INSTRUMENT

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert® SA Nasal Complete

FDA 510(k)

FDA Class 2 ·Microbiology

LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727

FDA 510(k)

FDA Class 2 ·Microbiology

XPERT MRSA/SA SSTI ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

MRSA/SA ELITE MGB

FDA 510(k)

FDA Class 2 ·Microbiology

ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM

FDA 510(k)

FDA Class 2 ·Microbiology

ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit

FDA 510(k)

FDA Class 2 ·Microbiology

APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER

FDA 510(k)

FDA Class 2 ·Immunology

AmpliVue Trichomonas Assay

FDA 510(k)

FDA Class 2 ·Immunology

BD MAX CDIFF ASSAY, BD MAX INSTRUMENT

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems

FDA 510(k)

FDA Class 2 ·Immunology

cobas Cdiff nucleic acid test for use on the cobas Liat System

FDA 510(k)

FDA Class 2 ·Microbiology

Simplexa C. difficile Direct; Simplexa C. difficile Positive Control Pack

FDA 510(k)

FDA Class 2 ·Microbiology

Aptima Trichomonas vaginalis Assay

FDA 510(k)

FDA Class 2 ·Immunology