2,207 results · 43ms · Sources: EU EUDAMED, US FDA

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

APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM

FDA 510(k)
FDA Class 1 ·Microbiology

GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199

FDA 510(k)
FDA Class 1 ·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

Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument

FDA 510(k)
FDA Class 2 ·Microbiology

Aptima Combo 2 Assay (Panther System)

FDA 510(k)
FDA Class 2 ·Microbiology

FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System

FDA 510(k)
FDA Class 2 ·Microbiology

NxTAG® Respiratory Pathogen Panel

FDA 510(k)
FDA Class 2 ·Microbiology

GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE, MODEL 1091

FDA 510(k)
FDA Class 2 ·Microbiology

TAG RESPIRATORY VIRAL PANEL TAG DATA ANALYSIS SOFTWARE (TDAS RVP-I)

FDA 510(k)
FDA Class 2 ·Microbiology

GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST

FDA 510(k)
FDA Class 2 ·Microbiology

GEN-PROBE APTIMA COMBO 2 ASSAY

FDA 510(k)
FDA Class 2 ·Microbiology

VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)

FDA 510(k)
FDA Class 2 ·Microbiology

SIMPLEXA FLU A/B & RSV

FDA 510(k)
FDA Class 2 ·Microbiology

GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE MODEL#1091

FDA 510(k)
FDA Class 2 ·Microbiology

Aptima Neisseria gonorrhoeae Assay

FDA 510(k)
FDA Class 2 ·Microbiology

GONOSTAT

FDA 510(k)
FDA Class 2 ·Microbiology

ARIES® Flu A/B & RSV Assay

FDA 510(k)
FDA Class 2 ·Microbiology

GEN-PROBE PACE SYSTEM FOR NEISSERIA GONORRHOEAE

FDA 510(k)
FDA Class 2 ·Microbiology