cobas Cdiff Positive and Negative Control Kit for use on the cobas Liat System

FDA registration

ROCHE MOLECULAR SYSTEMS, INC.·2 products·🇺🇸 United States

Lyra Direct C.difficile Assay

FDA registration

Ortho-Clinical Diagnostics, Inc.·2 products·🇺🇸 United States

Portrait Toxigenic C. difficile Assay

FDA UDI

GREAT BASIN SCIENTIFIC, INC.·B178GBCDIFF100·C. diff Assay Cartridge and Sample Prep Device.

Lyra

FDA UDI

QUIDEL CORPORATION·30014613311058·Lyra Direct CDIFF Assay

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