QIAstat-Dx Respiratory Panel Mini

FDA 510(k)

FDA Class 2 ·Microbiology

Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay

FDA 510(k)

FDA Class 2 ·Microbiology

LIAISON PLEX Respiratory Flex Assay

FDA 510(k)

FDA Class 2 ·Microbiology

BD Respiratory Viral Panel for BD MAX™ System; BD Respiratory Viral Panel-SCV2 for BD MAX™ System

FDA 510(k)

FDA Class 2 ·Microbiology

Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel

FDA 510(k)

FDA Class 2 ·Microbiology

cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test

FDA 510(k)

FDA Class 2 ·Microbiology

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

GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088

FDA 510(k)

FDA Class 1 ·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

COBAS 4800 CT / NG TEST

FDA 510(k)

FDA Class 1 ·Microbiology

GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS

FDA 510(k)

FDA Class 1 ·Microbiology

BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY

FDA 510(k)

FDA Class 1 ·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