GenePOC CDiff

FDA 510(k)

FDA Class 2 ·Microbiology

BD MAX CTGCTV2, BD MAX System

FDA 510(k)

FDA Class 2 ·Immunology

Great Basin Toxigenic C. difficile Direct Test (CDF2)

FDA 510(k)

FDA Class 2 ·Microbiology

APTIMA TRICHOMONAS VAGINALIS ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit

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

AMPLIVUE C. DIFFICILE ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

Solana Trichomonas Assay

FDA 510(k)

FDA Class 2 ·Immunology

BD MAX CT/GC/TV, BD MAX INSTRUMENT

FDA 510(k)

FDA Class 2 ·Immunology

BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY

FDA 510(k)

FDA Class 2 ·Immunology

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

Xpert® Xpress CoV-2 plus

FDA 510(k)

FDA Class 2 ·Microbiology

Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)

FDA 510(k)

FDA Class 2 ·Microbiology

Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit

FDA 510(k)

FDA Class 2 ·Microbiology