OQW / 2009 h1n1 influenza virus (swine origin), nucleic acid or antigen, detection and identification

FDA registration

MONOCENT INC.·1 product·🇺🇸 United States

JBAIDS

FDA UDI

BIOFIRE DEFENSE, LLC·00851458005075·JBAIDS IVD Influenza A Subtyping Kit

Simplexa™ Influenza A H1N1 (2009)

FDA UDI

DIASORIN MOLECULAR LLC·20816101025521·

Xpert Flu

FDA UDI

CEPHEID·07332940001070·Xpert Flu kit; 10 test kit

PROFAST+ ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

JBAIDS INFLUENZA A SUBTYPING KIT

FDA 510(k)

FDA Class 2 ·Microbiology

CDC INFLUENZA 2009 A(H1N1)PDM REAL-TIME RT-PCR PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

PRODESSE PROFAST+ ASSAY

FDA 510(k)

FDA Class 2 ·Microbiology

SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500

FDA 510(k)

FDA Class 2 ·Microbiology

XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV)

FDA 510(k)

FDA Class 2 ·Microbiology

XPERT FLU, GENEXPERT DX SYSTEMS, GENEXPERT INFINITY SYSTEM, GENEXPERT SYSTEM SOFTWARE VERISIONS 2.1 AND 4.0

FDA 510(k)

FDA Class 2 ·Microbiology

CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

ePlex Respiratory Pathogen (RP) Panel

FDA registration

GENMARK DIAGNOSTICS, INC.·10 products·🇺🇸 United States

ePlex® Respiratory Pathogen (RP) Panel

FDA registration

HOCHUEN MEDICAL SDN. BHD.·10 products·🇲🇾 Malaysia

ePlex® Respiratory Pathogen (RP) Panel

FDA registration

Hochuen Medical Technology Co.,Ltd.·10 products·🇨🇳 China

2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification

FDA classification

FDA Class 2 ·2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification

ePlex System

FDA UDI

GENMARK DIAGNOSTICS, INC.·00857167005023·ePlex Sample Delivery Device RP Panel

ePlex System

FDA UDI

GENMARK DIAGNOSTICS, INC.·00857167005016·Respiratory Panel Cartridge