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