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

XPERT FLU/RSV XC ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

ID NOW Influenza A & B 2

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

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

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

VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP)

FDA 510(k)

FDA Class 2 ·Microbiology

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

FDA 510(k)

FDA Class 2 ·Microbiology

LYRA ADENOVIRUS ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

MODIFICATION TO PROFLU+ ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

ADENOVIRUS R-GENE US

FDA 510(k)

FDA Class 2 ·Microbiology

Respiratory Virus Panel Nucleic Acid Assay System

FDA classification

FDA Class 2 ·Respiratory Virus Panel Nucleic Acid Assay System