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

BD MAX CDIFF ASSAY, BD MAX INSTRUMENT

FDA 510(k)

FDA Class 2 ·Microbiology

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

GenePOC CDiff

FDA 510(k)

FDA Class 2 ·Microbiology

Great Basin Toxigenic C. difficile Direct Test (CDF2)

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA 510(k)

FDA Class 2 ·Microbiology

AMPLIVUE C. DIFFICILE ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

cobas Cdiff Test

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA 510(k)

FDA Class 2 ·Microbiology

QUIDEL MOLECULAR DIRECT C. DIFFICILE ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

IMDX C.DIFFICILE FOR ABBOTT M2000

FDA 510(k)

FDA Class 2 ·Microbiology

Solana C. difficile Assay

FDA 510(k)

FDA Class 2 ·Microbiology

ARTUS C. DIFFICILE QS-RGQ MDX KIT

FDA 510(k)

FDA Class 2 ·Microbiology

VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)

FDA 510(k)

FDA Class 2 ·Microbiology

C. Difficile Toxin Gene Amplification Assay

FDA classification

FDA Class 2 ·C. Difficile Toxin Gene Amplification Assay

VIRTUOST

FDA 510(k)

FDA Class 2 ·Radiology

VirtuOst

FDA 510(k)

FDA Class 2 ·Radiology

OdneClean

FDA 510(k)

FDA Class 2 ·Dental