FDA Product Code
FDA Product Code PCH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.3990
510(k) Clearances — 38 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253722 | LIAISON PLEX Gastrointestinal Flex Assay | Luminex Corporation | 2026-05-19 | Traditional | PDF ↗ |
| K254032 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | QIAGEN GmbH | 2026-03-09 | Traditional | PDF ↗ |
| K251721 | Xpert GI Panel | Cepheid | 2026-01-16 | Traditional | PDF ↗ |
| K252329 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | QIAGEN GmbH | 2025-10-22 | Traditional | PDF ↗ |
| K251993 | Panther Fusion GI Expanded Bacterial Assay | Hologic, Inc. | 2025-09-25 | Traditional | PDF ↗ |
| K251868 | Panther Fusion GI Bacterial Assay | Hologic | 2025-09-25 | Traditional | PDF ↗ |
| K250324 | QIAstat-Dx GI Panel 2 Mini B | QIAGEN GmbH | 2025-02-28 | Special | PDF ↗ |
| K243885 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid | Biofire Diagnostics, LLC | 2025-01-16 | Special | PDF ↗ |
| K242877 | BioCode Gastrointestinal Pathogen Panel (GPP) | Applied BioCode, Inc. | 2025-01-10 | Traditional | PDF ↗ |
| K243813 | QIAstat-Dx GI Panel 2 Mini B&V | QIAGEN GmbH | 2025-01-08 | Special | PDF ↗ |
| K242367 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | Biofire Diagnostics, LLC | 2024-11-07 | Traditional | PDF ↗ |
| K220062 | QIAstat-Dx Gastrointestinal Panel 2 | QIAGEN GmbH | 2024-05-31 | Traditional | PDF ↗ |
| K232672 | EasyScreen Gastrointestinal Parasite Detection Kit | Genetic Signatures Limited | 2024-05-29 | Traditional | PDF ↗ |
| K230404 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | Biofire Diagnostics, LLC | 2023-03-16 | Special | PDF ↗ |
| K220607 | BD MAX Enteric Viral Panel | Becton, Dickinson and Company | 2022-09-21 | Traditional | PDF ↗ |
| K220193 | BD MAX Enteric Parasite Panel | Becton, Dickinson and Company | 2022-08-19 | Traditional | PDF ↗ |
| K191161 | xTAG Gastrointestinal Pathogen Panel (GPP) | Luminex Molecular Diagnostics, Inc. | 2019-11-12 | Special | PDF ↗ |
| K191160 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | Luminex Molecular Diagnostics, Inc. | 2019-11-04 | Special | PDF ↗ |
| K182703 | EntericBio Dx Assay | Serosep , Ltd. | 2019-06-19 | Traditional | PDF ↗ |
| K190585 | Biocode Gastrointestinal Pathogen Panel (GPP) | Applied BioCode, Inc. | 2019-06-05 | Traditional | PDF ↗ |
| K183030 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | Luminex Molecular Diagnostics, Inc. | 2018-11-30 | Special | PDF ↗ |
| K183023 | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | Luminex Molecular Diagnostics, Inc. | 2018-11-30 | Special | PDF ↗ |
| K181427 | BD MAX Enteric Viral Panel, BD MAX Instrument | Becton, Dickinson and Company | 2018-11-29 | Traditional | PDF ↗ |
| K180041 | BioCode Gastrointestinal Pathogen Panel (GPP) | Applied BioCode, Inc. | 2018-09-28 | Traditional | PDF ↗ |
| K170308 | BD MAX Extended Enteric Bacterial Panel, BD MAX System | Becton, Dickinson and Company | 2017-05-02 | Traditional | PDF ↗ |
| K160459 | FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch | Biofire Diagnostics, LLC | 2016-04-01 | Special | PDF ↗ |
| K152955 | Great Basin Shiga Toxin Direct Test | Great Basin Scientific, Inc. | 2016-03-22 | Traditional | PDF ↗ |
| K143648 | BD MAX Enteric Parasite Panel, BD MAX Instrument | Becton, Dickinson and Company | 2015-08-25 | Traditional | PDF ↗ |
| K143005 | FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 | Biofire Diagnostics, LLC | 2015-02-19 | Traditional | PDF ↗ |
| K142501 | 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 | Cepheid | 2014-11-26 | Traditional | PDF ↗ |
| K140647 | XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP) | Luminex Molecular Diagnostics, Inc. | 2014-10-24 | Traditional | PDF ↗ |
| K142033 | VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP) | Nanospere,Inc. | 2014-10-10 | Traditional | PDF ↗ |
| K140377 | XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) | Luminex Molecular Diagnostics, Inc. | 2014-09-16 | Traditional | PDF ↗ |
| K140083 | VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP) | Nanosphere, Inc. | 2014-06-20 | Traditional | PDF ↗ |
| K140407 | FILMARRAY GASTROINTESTINAL (GI) PANEL | Biofire Diagnostics | 2014-05-02 | Traditional | PDF ↗ |
| K121894 | XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX | Luminex Molecular Diagnostics, Inc. | 2013-03-21 | Traditional | PDF ↗ |
| K123274 | PROGASTRO SSCS ASSAY | Gen-Probe Prodesse, Inc. | 2013-01-16 | Traditional | PDF ↗ |
| DEN130003 | XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS) | Luminex Molecular Diagnostics, Inc. | 2013-01-14 | Post-NSE | — |
Product code PCH · Class II · Microbiology. Data: openFDA.