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

ID NOW RSV Control Swab Kit

FDA UDI

Alere Scarborough, Inc.·10811877010538·Control Swabs intended for use only with the ID...

Lyra

FDA UDI

DIAGNOSTIC HYBRIDS, INC.·30014613311003·Lyra FLU A+B Assay

Alere™ i Influenza A & B Control Swab Kit

FDA UDI

Alere Scarborough, Inc.·10811877010811·Control Swabs intended for use only with the Al...

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

FDA UDI

Roche Molecular Systems, Inc.·00875197005950·

Alere i RSV Control Swab Kit

FDA UDI

Alere Scarborough, Inc.·10811877010132·Control Swabs intended for use only with the Al...

ID NOW RSV

FDA UDI

Alere Scarborough, Inc.·10811877010521·A rapid, automated, molecular test for the qual...

Alere i Influenza A & B 2

FDA UDI

Alere Scarborough, Inc.·10811877010019·A rapid, automated, molecular test for the qual...