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

QUIDEL MOLECULAR INFLUENZA A + B ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

Accula RSV Test

FDA 510(k)

FDA Class 2 ·Microbiology

VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST

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

ALERE I INFLUENZA A & B

FDA 510(k)

FDA Class 2 ·Microbiology

ePlex Respiratory Pathogen Panel

FDA 510(k)

FDA Class 2 ·Microbiology

ABBOTT PLEX-ID FLU ASSAY

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

Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit

FDA 510(k)

FDA Class 2 ·Microbiology

Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack

FDA 510(k)

FDA Class 2 ·Microbiology

FILMARRAY RP PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST

FDA 510(k)

FDA Class 2 ·Microbiology

BioCode Respiratory Pathogen Panel (RPP)

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

QUIDEL MOLECULAR RSV + HMPV ASSAY

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