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

GenePOC Carba

FDA 510(k)

FDA Class 2 ·Microbiology

BVI SLING

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

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

100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL

FDA 510(k)

FDA Class 2 ·Orthopedic

ABG III MONOLITHIC HIP STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

ABG II MONOLITHIC HIP STEM

FDA 510(k)

FDA Class 2 ·Orthopedic

EQUATOR PLUS ACETABULAR CUP SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

Ventilatory Electrical Impedance Tomograph

FDA classification

FDA Class 2 ·Ventilatory Electrical Impedance Tomograph

Non-Factor Replacement Product Test System

FDA classification

FDA Class 2 ·Non-Factor Replacement Product Test System