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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® 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
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)
Disposable Needle Guides for use with Mindray 65EC10EA, 6CV1(s,P), CB10-4(s,P,E), V10-4(s), V10-4B(s,p), V11-3(E), V11-3B(E), V11-3W(s,E), V11-3H(E,U); Wisonic EV10-4; Landwind EC4-9; Samsung EC4-9IS, EC4-9ES, ER4-9ES; GE IC5-9; VINNO G4-9E, X4-9E; Zoncare 6E1CD Ultrasound Transducers
JingFang Precision Medical Device(Shenzhen) Co., Ltd.
DE-001
In Commercial Distribution

  • 16971554725019 ()
  • 06971554725012 ()
DE-001

  • Needle guide, single-use
Navigator, Navi-Port Pendant
Medical Illumination International Inc.
NAV-NP-
In Commercial Distribution

  • 01816835023942 ()
  • 00816835023943 ()


  • General utility supply system, ceiling-mounted
Navigator, Dual Arm Retractable Pendant
Medical Illumination International Inc.
NAV-DAR-
In Commercial Distribution

  • 01816835023935 ()
  • 00816835023936 ()


  • General utility supply system, ceiling-mounted
Navigator, Single Arm Retractable Pendant
Medical Illumination International Inc.
NAV-SAR-
In Commercial Distribution

  • 01816835023928 ()
  • 00816835023929 ()


  • General utility supply system, ceiling-mounted
Navigator, Dual Arm Fixed Pendant
Medical Illumination International Inc.
NAV-DAF-
In Commercial Distribution

  • 01816835023911 ()
  • 00816835023912 ()


  • General utility supply system, ceiling-mounted
Navigator, Single Arm Fixed Pendant
Medical Illumination International Inc.
NAV-SAF-
In Commercial Distribution

  • 01816835023904 ()
  • 00816835023905 ()


  • General utility supply system, ceiling-mounted
Medical Ceiling Supply Units
Maquet (Suzhou) Co. LTD
MODUEVO BRIDGE
In Commercial Distribution

  • 06970283131026 ()


  • General utility supply system, ceiling-mounted
Medical Ceiling Supply Units
Maquet (Suzhou) Co. LTD
CARGOLIFT
In Commercial Distribution

  • 06970283131019 ()


  • General utility supply system, ceiling-mounted
Medical Ceiling Supply Units
Maquet (Suzhou) Co. LTD
ENERGY
In Commercial Distribution

  • 06970283131002 ()


  • General utility supply system, ceiling-mounted
Medical Ceiling Supply Units
Maquet (Suzhou) Co. LTD
PLG-II
In Commercial Distribution

  • 06970283130999 ()


  • General utility supply system, ceiling-mounted
Medical Ceiling Supply Units
Maquet (Suzhou) Co. LTD
MODUEVO-MA
In Commercial Distribution

  • 06970283130982 ()


  • General utility supply system, ceiling-mounted
Equipment Management System
STRYKER COMMUNICATIONS INC.
0682400550
In Commercial Distribution

  • 07613327400502 ()
0682400550

  • General utility supply system, ceiling-mounted
No Description
Ondal Medical Systems GmbH
M6
In Commercial Distribution

  • 04061591000202 ()


  • General utility supply system, ceiling-mounted
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