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

FDA registration

MONOCENT INC.·1 product·🇺🇸 United States

AV Avantage™ A/H5N1 Flu Test

FDA registration

ARBOR VITA CORPORATION·1 product·🇺🇸 United States

JBAIDS

FDA UDI

BIOFIRE DEFENSE, LLC·00851458005082·JBAIDS IVD Influenza A/H5 Detection Kit

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

INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET

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

AVC A/H5N1 FLU TEST

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 DETECTION AND CHARACTERIZATION PANEL

FDA 510(k)

FDA Class 2 ·Microbiology

JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136

FDA 510(k)

FDA Class 2 ·Microbiology