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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.
NANOSPHERE, INC.
20-006-023
Not in Commercial Distribution

  • 00857573006041 ()


  • 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
30-002-023
In Commercial Distribution

30-002-023

  • 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
20-009-023
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
NEG external qc to monitor the performance of in vitro laboratory nucleic acid testing procedures for the qualitative detection of pathogens included in the BIOFIRE SPOTFIRE R Panel, BIOFIRE SPOTFIRE R Panel Mini, BIOFIRE SPOTFIRE R/ST Panel and BIOFIRE SPOTFIRE R/ST Panel Mini
Mmqci
v.00
In Commercial Distribution

  • 00852720008107 ()
M42738

  • Multiple-genus respiratory virus nucleic acid IVD, control
Healgen (DrugConfirm) - 4 panel Cup AMP1000/COC300/MET1000/OPI2000
CONFIRM BIOSCIENCES, INC.
CB-HE-CUP-242
In Commercial Distribution

  • 00856464008348 ()


  • Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical
  • Cocaine/cocaine metabolite IVD, reagent
  • Methamphetamine-specific IVD, reagent
  • Opiate/opiate metabolite IVD, reagent
eSensor® Respiratory Viral Panel Cartridge Pouch (RVP) (8)
GENMARK DIAGNOSTICS, INC.
eSensor® Respiratory Viral Panel (RVP)
Not in Commercial Distribution

  • 00857167005092 ()
KT021620

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
eSensor® Respiratory Viral Panel Detection Reagents (RVP) (48)
GENMARK DIAGNOSTICS, INC.
eSensor® Respiratory Viral Panel (RVP)
Not in Commercial Distribution

  • 00857167005122 ()
MT005101

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
ATLAS Stim Headbox with Nihon Kohden passive side panel.
NEURALYNX, INC.
NK
In Commercial Distribution

  • 00867718000285 ()
31-0601-0077

  • Somatosensory electrical stimulation system
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