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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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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
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.
30-002-022
Not in Commercial Distribution

  • 00857573006362 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
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.
20-011-022
Not in Commercial Distribution

  • 00857573006317 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
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.
20-009-022
Not in Commercial Distribution

  • 00857573006256 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
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
RIM E. coli O157:H7 Latex 50TST/KT
REMEL, INC.
R24250
In Commercial Distribution

  • 00848838026768 ()
R24250

  • Escherichia coli antigen IVD, kit, rapid agglutination, clinical
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