2,207 results · 45ms · Sources: EU EUDAMED, US FDA

Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System

FDA 510(k)
FDA Class 2 ·Microbiology

XPERT FLU

FDA 510(k)
FDA Class 2 ·Microbiology

Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I)

FDA 510(k)
FDA Class 2 ·Microbiology

BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY

FDA 510(k)
FDA Class 2 ·Microbiology

SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK

FDA 510(k)
FDA Class 2 ·Microbiology

GEN-PROBE APTIMA COMBO 2 ASSAY

FDA 510(k)
FDA Class 2 ·Microbiology

XPERT FLU/RSV XC ASSAY

FDA 510(k)
FDA Class 2 ·Microbiology

COBAS CT/NG V2.0 TEST

FDA 510(k)
FDA Class 2 ·Microbiology

ID NOW Influenza A & B 2

FDA 510(k)
FDA Class 2 ·Microbiology

GONOSTAT GONOCOCCAL DETECTION KIT

FDA 510(k)
FDA Class 2 ·Microbiology

cobas® CT/NG v2.0 Test

FDA 510(k)
FDA Class 2 ·Microbiology

Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System

FDA 510(k)
FDA Class 2 ·Microbiology

XTAG RESPIRATORY VIRAL PANEL

FDA 510(k)
FDA Class 2 ·Microbiology

XPERT CT/NG

FDA 510(k)
FDA Class 2 ·Microbiology

NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software

FDA 510(k)
FDA Class 2 ·Microbiology

cobas CT/NG for use on cobas 6800/8800 systems

FDA 510(k)
FDA Class 2 ·Microbiology

HYBRID CAPTURE II CT/GC TEST

FDA 510(k)
FDA Class 2 ·Microbiology

Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack

FDA 510(k)
FDA Class 2 ·Microbiology

Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV

FDA 510(k)
FDA Class 2 ·Microbiology

TIGRIS DTS GEN-PROBE APTIMA COMBO 2 ASSAY

FDA 510(k)
FDA Class 2 ·Microbiology