Idylla Respiratory (IFV-RSV) Panel

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Respiratory Panel (RP) for use with FilmArray Torch

FDA 510(k)

FDA Class 2 ·Microbiology

FILMARRAY RP PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

PRODESSE PROADENO

FDA 510(k)

FDA Class 2 ·Microbiology

Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit

FDA 510(k)

FDA Class 2 ·Microbiology

Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes

FDA 510(k)

FDA Class 2 ·Microbiology

Solana Influenza A+B Assay

FDA 510(k)

FDA Class 2 ·Microbiology

XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1)

FDA 510(k)

FDA Class 2 ·Microbiology

FILMARRAY RESPIRATORY PANEL (RP)

FDA 510(k)

FDA Class 2 ·Microbiology

PROFLU+ ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

PROADENO+ ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

ID-TAG RESPIRATORY VIRAL PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

FILMARRAY RESPIRATORY PANEL (RP)

FDA 510(k)

FDA Class 2 ·Microbiology

Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2

FDA 510(k)

FDA Class 2 ·Microbiology

cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System

FDA 510(k)

FDA Class 2 ·Microbiology

FilmArray Respiratory Panel EZ (RP EZ)

FDA 510(k)

FDA Class 2 ·Microbiology

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

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

FDA 510(k)

FDA Class 2 ·Microbiology