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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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Panther Fusion® Specimen Lysis Tubes.
Hologic, Inc.
SPECIMEN LYSIS TUBES, IVD
In Commercial Distribution

  • 15420045509238 ()
PRD-04339

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Hologic, Inc.
PROADENO+ KIT, 100 REACTIONS
Not in Commercial Distribution

  • 15420045506381 ()
303675

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Hologic, Inc.
PROFLU+ ASSAY KIT, 1,500 REACTIONS
Not in Commercial Distribution

  • 15420045506343 ()
303123

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Hologic, Inc.
PROFLU+ ASSAY KIT, 2,000 REACTIONS
Not in Commercial Distribution

  • 15420045506336 ()
303121

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Hologic, Inc.
PRODESSE PROFLU+ ASSAY
Not in Commercial Distribution

  • 15420045506329 ()
303111

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Biocartis NV
1.0
Not in Commercial Distribution

  • 15415219000635 ()
  • 05415219000638 ()
A1030/6

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
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.
20-011-023
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.
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
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