|
Device |
gastrointestinal pathogen panel multiplex nucleic acid-based assay system |
Definition |
A gastrointestinal pathogen panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and/or symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. |
Product Code | PCH |
Regulation Number |
866.3990
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
APPLIED BIOCODE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BECTON, DICKINSON AND COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
BIOFIRE DIAGNOSTICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOFIRE DIAGNOSTICS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CEPHEID |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GEN-PROBE PRODESSE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GREAT BASIN SCIENTIFIC, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
|
GRANTED
|
1
|
|
SUBSTANTIALLY EQUIVALENT
|
7
|
1. K121894 XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DAT ...
|
2. K140377 XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DA ...
|
3. K140647 XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DAT ...
|
4. K183023 xTAG Gastrointestinal Pathogen Panel (GPP), xTAG D ...
|
5. K183030 xTAG Gastrointestinal Pathogen Panel (GPP), xTAG D ...
|
6. K191160 xTAG Gastrointestinal Pathogen Panel (GPP), xTAG D ...
|
7. K191161 xTAG Gastrointestinal Pathogen Panel (GPP)
|
NANOSPERE,INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NANOSPHERE, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SEROSEP, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|