FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K190585 |
Applied Biocode, Inc. |
Biocode Gastrointestinal Pathogen Panel (GPP) |
06/05/2019 |
K180041 |
Applied Biocode, Inc. |
BioCode Gastrointestinal Pathogen Panel (GPP) |
09/28/2018 |
K220193 |
Becton, Dickinson and Company |
BD MAX Enteric Parasite Panel |
08/19/2022 |
K143648 |
BECTON, DICKINSON AND COMPANY |
BD MAX Enteric Parasite Panel, BD MAX Instrument |
08/25/2015 |
K220607 |
Becton, Dickinson and Company |
BD MAX Enteric Viral Panel |
09/21/2022 |
K181427 |
Becton, Dickinson and Company |
BD MAX Enteric Viral Panel, BD MAX Instrument |
11/29/2018 |
K170308 |
BECTON, DICKINSON AND COMPANY |
BD MAX Extended Enteric Bacterial Panel, BD MAX System |
05/02/2017 |
K140407 |
Biofire Diagnostics |
FILMARRAY GASTROINTESTINAL (GI) PANEL |
05/02/2014 |
K230404 |
BioFire Diagnostics, LLC |
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel |
03/16/2023 |
K143005 |
BioFire Diagnostics, LLC |
FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 |
02/19/2015 |
K160459 |
BIOFIRE DIAGNOSTICS, LLC |
FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch |
04/01/2016 |
K142501 |
CEPHEID |
Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System |
11/26/2014 |
K123274 |
GEN-PROBE PRODESSE, INC. |
PROGASTRO SSCS ASSAY |
01/16/2013 |
K152955 |
GREAT BASIN SCIENTIFIC, INC. |
Great Basin Shiga Toxin Direct Test |
03/22/2016 |
K191161 |
Luminex Molecular Diagnostics, Inc. |
xTAG Gastrointestinal Pathogen Panel (GPP) |
11/12/2019 |
DEN130003 |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS) |
01/14/2013 |
K183023 |
Luminex Molecular Diagnostics, Inc. |
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) |
11/30/2018 |
K183030 |
Luminex Molecular Diagnostics, Inc. |
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) |
11/30/2018 |
K191160 |
Luminex Molecular Diagnostics, Inc. |
xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) |
11/04/2019 |
K140377 |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) |
09/16/2014 |
K121894 |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX |
03/21/2013 |
K140647 |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP) |
10/24/2014 |
K142033 |
NANOSPERE,INC. |
VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP) |
10/10/2014 |
K140083 |
NANOSPHERE, INC |
VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP) |
06/20/2014 |
K182703 |
Serosep, Ltd. |
EntericBio Dx Assay |
06/19/2019 |