ID NOW Influenza A & B 2

FDA 510(k)

FDA Class 2 ·Microbiology

cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System

FDA 510(k)

FDA Class 2 ·Microbiology

XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA 510(k)

FDA Class 2 ·Microbiology

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