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

IMMUNOCARD STAT! RSV MODEL #750630

FDA 510(k)

FDA Class 1 ·Microbiology

SAS RSV TEST

FDA 510(k)

FDA Class 1 ·Microbiology

FITC MURINE MONOCLONAL ANTI-RSV IGG

FDA 510(k)

FDA Class 1 ·Microbiology

SOFIA(R) RSV FIA

FDA 510(k)

FDA Class 1 ·Microbiology

RSV ANTIGEN CONTROL SLIDES

FDA 510(k)

FDA Class 1 ·Microbiology

BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV

FDA 510(k)

FDA Class 1 ·Microbiology

BD VERITOR(TM) SYSTEM FOR THE RAPID DETECTION OF RSV

FDA 510(k)

FDA Class 1 ·Microbiology

RSV OIA

FDA 510(k)

FDA Class 1 ·Microbiology