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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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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
20-009-023
In Commercial Distribution

20-009-023

  • 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
20-011-023
In Commercial Distribution

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
In Commercial Distribution

20-006-023

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
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

  • 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)
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