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The Verigene® Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI).
NANOSPHERE, INC.
20-006-022
Not in Commercial Distribution
- 00857573006157 ()
- 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.
NANOSPHERE, INC.
20-011-023
Not in Commercial Distribution
- 00857573006089 ()
- 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.
NANOSPHERE, INC.
30-002-023
Not in Commercial Distribution
- 00857573006065 ()
- 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.
NANOSPHERE, INC.
20-009-023
Not in Commercial Distribution
- 00857573006058 ()
- 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.
NANOSPHERE, INC.
20-006-023
Not in Commercial Distribution
- 00857573006041 ()
- Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
Kit containing calibrators and controls for MDx 3000.
APPLIED BIOCODE, INC.
1
In Commercial Distribution
- 00851034007028 ()
64-C0002
- Multiple-type gastrointestinal pathogen nucleic acid IVD, calibrator
In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of gastrointestinal pathogens.
APPLIED BIOCODE, INC.
1
In Commercial Distribution
- 00851034007011 ()
- 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
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)