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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
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)
Helix Elite™ Molecular Standards Inactivated Rotavirus Strain Simian SA-11
MICROBIOLOGICS INC.
HE0027N
In Commercial Distribution

  • 10845357042016 ()
HE0027N

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Cyclospora cayetanensis Synthetic DNA
MICROBIOLOGICS INC.
HE0025S
Not in Commercial Distribution

  • 10845357041965 ()
HE0025S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Dientamoeba fragilis Synthetic DNA
MICROBIOLOGICS INC.
HE0015S
Not in Commercial Distribution

  • 10845357041873 ()
HE0015S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Norovirus GI.1 Synthetic RNA
MICROBIOLOGICS INC.
HE0013S
In Commercial Distribution

  • 10845357041859 ()
HE0013S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Norovirus GII.4 Synthetic RNA
MICROBIOLOGICS INC.
HE0012S
In Commercial Distribution

  • 10845357041842 ()
HE0012S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Entamoeba dispar Synthetic DNA
MICROBIOLOGICS INC.
HE0007S
Not in Commercial Distribution

  • 10845357041798 ()
HE0007S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
Helix Elite™ Molecular Standards Entamoeba histolytica Synthetic DNA
MICROBIOLOGICS INC.
HE0006S
Not in Commercial Distribution

  • 10845357041781 ()
HE0006S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
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