Visby Medical Sexual Health Test

FDA 510(k)

FDA Class 2 ·Microbiology

cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit

FDA 510(k)

FDA Class 2 ·Microbiology

binx health io CT/NG Assay

FDA 510(k)

FDA Class 2 ·Microbiology

cobas® liat CT/NG nucleic acid test

FDA 510(k)

FDA Class 2 ·Microbiology

Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris

FDA 510(k)

FDA Class 2 ·Microbiology

BD CTGCTV2

FDA 510(k)

FDA Class 2 ·Microbiology

cobas CTNG for use on cobas 6800/8800 systems

FDA 510(k)

FDA Class 2 ·Microbiology

Aptima Combo 2 Assay (Panther System)

FDA 510(k)

FDA Class 2 ·Microbiology

Alinity m STI Assay

FDA 510(k)

FDA Class 2 ·Microbiology

Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)

FDA 510(k)

FDA Class 2 ·Microbiology

NeuMoDx CT/NG Assay 2.0

FDA 510(k)

FDA Class 2 ·Microbiology

Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit

FDA 510(k)

FDA Class 2 ·Microbiology

Aptima Mycoplasma genitalium Assay

FDA 510(k)

FDA Class 2 ·Microbiology

binx io CT/NG Assay and binx io CT/NG System

FDA 510(k)

FDA Class 2 ·Microbiology

cobas® liat CT/NG/MG nucleic acid test

FDA 510(k)

FDA Class 2 ·Microbiology

BD CTGCTV2

FDA 510(k)

FDA Class 2 ·Microbiology

Visby Medical Sexual Health

FDA 510(k)

FDA Class 2 ·Microbiology

Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit

FDA 510(k)

FDA Class 2 ·Microbiology

Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit

FDA 510(k)

FDA Class 2 ·Microbiology

Alinity m STI Assay

FDA 510(k)

FDA Class 2 ·Microbiology