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The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
LUMINEX CORPORATION
20-011-023
20-011-023
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
The Verigene® Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
LUMINEX CORPORATION
20-006-023
20-006-023
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
The xTAG® Gastrointestinal Pathogen Panel (GPP) is a qualitative multiplex test intended for the simultaneous detection and identification of nucleic acids from multiple gastroenteritis causing viruses, parasites and bacteria (including toxin gene detection) in human stool samples that are fresh, frozen or in a holding medium, from individuals with signs and symptoms of infectious colitis or gastroenteritis.
Luminex Molecular Diagnostics, Inc
I032C0316
In Commercial Distribution
- 00840487100493 ()
I032C0316
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
The EasyScreen™ Gastrointestinal Parasite PCR Positive Control (PC-PROT-001) is a control material for nucleic acid testing of patient clinical samples. It is designed to provide a positive PCR signal for each of the protozoan targets in the EasyScreen™ Gastrointestinal Parasite Detection Kit (EP005). The Positive Control does not require processing and is designed to be added directly to the PCR mastermix when a positive signal in all detection channels is required for quality control purposes.
This Positive Control demonstrates that all PCR targets are being detected as expected, and does not provide any results from clinical specimens. This Positive Control is for Investigational in vitro Diagnostic (IVD) Use Only in hospital and pathology laboratories or similar, by trained personnel.
GENETIC SIGNATURES LIMITED
1
In Commercial Distribution
- 09351179004070 ()
PC-PROT-001
- Multiple-type gastrointestinal pathogen nucleic acid IVD, control
RIM E. coli O157:H7 Latex 50TST/KT
REMEL, INC.
R24250
In Commercial Distribution
- 00848838026768 ()
R24250
- Escherichia coli antigen IVD, kit, rapid agglutination, clinical
No Description
QIAGEN GmbH
V1
In Commercial Distribution
- 04053228049166 ()
691424
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
QIAGEN GmbH
V1
In Commercial Distribution
- 04053228048381 ()
691423
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
QIAGEN GmbH
V2
In Commercial Distribution
- 04053228043249 ()
691421
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Kit BD MAX Enteric Viral Panel
BECTON, DICKINSON AND COMPANY
443985
In Commercial Distribution
- 00382904439859 ()
443985
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Kit BD MAX Enteric Parasite Panel
BECTON, DICKINSON AND COMPANY
442960
In Commercial Distribution
- 00382904429607 ()
442960
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
BD MAX™ Enteric Parasite Panel (US/CAN) Contains: 24 Master Mix, 24 Extraction Tubes, 24 1.5 mL Sample Buffer tubes, 25 Septum Caps, 24 Strips Containing, Wash Buffer, Elution Buffer, Neutralization Buffer
Geneohm Sciences Canada Inc
443380
Not in Commercial Distribution
- 00382904433802 ()
443380
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
424898
In Commercial Distribution
- 00815381020888 ()
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0116
In Commercial Distribution
- 00815381020109 ()
RFIT-ASY-0116
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
425089
In Commercial Distribution
- 00815381020963 ()
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0104
In Commercial Distribution
- 00815381020116 ()
RFIT-ASY-0104
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
QC Sets and Panels: Helix Elite™ Gastrointestinal (22 Targets) Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8236
In Commercial Distribution
- 70845357043060 ()
8236
- Multiple-type gastrointestinal pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Enteric Parasite Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8230
In Commercial Distribution
- 70845357042698 ()
8230
- Multiple-type gastrointestinal pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Enteric Pathogens Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8184
In Commercial Distribution
- 70845357041448 ()
8184
- Multiple-type gastrointestinal pathogen nucleic acid IVD, control
BD MAX™ Enteric Parasite Control Panel
MICROBIOLOGICS INC.
8204 BD MAX™ Enteric Parasite Control Panel
In Commercial Distribution
- 70845357041394 ()
8204
- Multiple-type gastrointestinal pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Enteric Parasite Verification Panel (Synthetic)
MICROBIOLOGICS INC.
8182
Not in Commercial Distribution
- 70845357041356 ()
8182
- Multiple-type gastrointestinal pathogen nucleic acid IVD, control