520 results
·
41ms
·
Sources: EU EUDAMED, US FDA
ARIES® Flu A/B & RSV Assay
FDA 510(k)
FDA Class 2
·Microbiology
XTAG RESPIRATORY VIRAL PANEL FAST, XTAG DATA ANALYSIS SOFTWARE FOR RVP FAST
FDA 510(k)
FDA Class 2
·Microbiology
PRODESSE PROFLU+ ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
JBAIDS Influenza A & B Detection Kit
FDA 510(k)
FDA Class 2
·Microbiology
Solana RSV+hMPV Assay
FDA 510(k)
FDA Class 2
·Microbiology
ARTUS INFL A/B RG RT-PCR KIT
FDA 510(k)
FDA Class 2
·Microbiology
LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER
FDA 510(k)
FDA Class 2
·Microbiology
MODIFICATION TO PROFLU+ ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
Panther Fusion AdV/hMPV/RV Assay
FDA 510(k)
FDA Class 2
·Microbiology
JBAIDS INFLUENZA A&B DETECTION KIT
FDA 510(k)
FDA Class 2
·Microbiology
QIAstat-Dx Respiratory Panel
FDA 510(k)
FDA Class 2
·Microbiology
IMDX FLU A/B AND RSV FOR ABBOTT M2000
FDA 510(k)
FDA Class 2
·Microbiology
ProFlu+ Assay
FDA 510(k)
FDA Class 2
·Microbiology
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)
FDA 510(k)
FDA Class 2
·Microbiology
Panther Fusion AdV/hMPV/RV Assay
FDA 510(k)
FDA Class 2
·Microbiology
Xpert Xpress Flu/RSV, 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
PROFLU+ ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System
FDA 510(k)
FDA Class 2
·Microbiology
FilmArray Respiratory Panel 2 (RP2)
FDA 510(k)
FDA Class 2
·Microbiology