Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)

FDA 510(k)

FDA Class 2 ·Microbiology

Panther Fusion AdV/hMPV/RV Assay

FDA 510(k)

FDA Class 2 ·Microbiology

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

ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG

FDA 510(k)

FDA Class 2 ·Microbiology

BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

PROFLU+ ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

PACE 2 NEISSERIA GONORRHOEAE PROBE CONFIRM. 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

MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01

FDA 510(k)

FDA Class 2 ·Microbiology

GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE

FDA 510(k)

FDA Class 2 ·Microbiology

ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE

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

BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA 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

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