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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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Helix Elite™ Molecular Standards: Synthetic Standard - 10845357041859

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: Synthetic Standard - 10845357041842

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: Synthetic Standard - 10845357041798

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: Synthetic Standard - 10845357041781

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

Clostridium difficile (CDF) Stool Sample Preparation Kit - 00840487101735

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).
LUMINEX CORPORATION
30-002-022
In Commercial Distribution

30-002-022

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

Clostridium difficile (CDF) Amplification Tray - 00840487101704

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).
LUMINEX CORPORATION
20-011-022
In Commercial Distribution

20-011-022

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

Clostridium difficile (CDF) Extraction Tray - 00840487101650

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).
LUMINEX CORPORATION
20-009-022
In Commercial Distribution

20-009-022

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

Clostridium difficile (CDF) Nucleic Acid Test Cartridge - 00840487101605

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).
LUMINEX CORPORATION
20-006-022
In Commercial Distribution

20-006-022

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

Enteric Pathogens (EP) Stool Sample Preparation Kit - 00840487101568

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

Enteric Pathogens (EP) Extraction Tray - 00840487101551

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
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