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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® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene® System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection.
NANOSPHERE, INC.
20-011-020
Not in Commercial Distribution

  • 00857573006294 ()


  • Multiple-genus respiratory virus 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.
20-011-023
Not in Commercial Distribution

  • 00857573006089 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, microarray
MONTHLY MAINTENANCE KIT 6-PACK, CM130 (Model Number 9756600; Primary DI Number 00851575007365) that contains 6 individual MONTHLY MAINTENANCE KITs (Model Number 9717300; Primary DI Number 00851575007242)
HACH COMPANY
9756600
In Commercial Distribution

  • 00851575007365 ()
9756600

  • Haemodialysis system chlorine monitor
MONTHLY MAINTENANCE KIT, CM130
HACH COMPANY
9717300
In Commercial Distribution

  • 00851575007242 ()
9717300

  • Haemodialysis system chlorine monitor
Allograft Strip IC 90mm
Rti Surgical, Inc.
803190
In Commercial Distribution

  • 00854095006993 ()


  • Bone matrix implant, human-derived
Allograft Strip IC 50mm
Rti Surgical, Inc.
803150
In Commercial Distribution

  • 00854095006986 ()


  • Bone matrix implant, human-derived
Allograft Paste 10cc
Rti Surgical, Inc.
801110
In Commercial Distribution

  • 00854095006979 ()


  • Bone matrix implant, human-derived
Allograft Paste 5cc
Rti Surgical, Inc.
801105
In Commercial Distribution

  • 00854095006962 ()


  • Bone matrix implant, human-derived
Allograft Paste 1cc
Rti Surgical, Inc.
801101
In Commercial Distribution

  • 00854095006955 ()


  • Bone matrix implant, human-derived
DBM Paste
Rti Surgical, Inc.
807891
In Commercial Distribution

  • 00854095006733 ()


  • Bone matrix implant, human-derived
DBM Paste
Rti Surgical, Inc.
807890
In Commercial Distribution

  • 00854095006726 ()


  • Bone matrix implant, human-derived
DBM Paste
Rti Surgical, Inc.
807875
In Commercial Distribution

  • 00854095006719 ()


  • Bone matrix implant, human-derived
DBM Paste
Rti Surgical, Inc.
807845
In Commercial Distribution

  • 00854095006702 ()


  • Bone matrix implant, human-derived
DBM Paste
Rti Surgical, Inc.
807830
In Commercial Distribution

  • 00854095006696 ()


  • Bone matrix implant, human-derived
DBM Paste
Rti Surgical, Inc.
807820
In Commercial Distribution

  • 00854095006689 ()


  • Bone matrix implant, human-derived
DBM Paste
Rti Surgical, Inc.
008890
In Commercial Distribution

  • 00854095006498 ()
008890

  • Bone matrix implant, human-derived
DBM Paste
Rti Surgical, Inc.
008850
In Commercial Distribution

  • 00854095006481 ()
008850

  • Bone matrix implant, human-derived
DBM Paste
Rti Surgical, Inc.
007891
In Commercial Distribution

  • 00854095006474 ()
007891

  • Bone matrix implant, human-derived
DBM Paste
Rti Surgical, Inc.
007890
In Commercial Distribution

  • 00854095006467 ()
007890

  • Bone matrix implant, human-derived
DBM Paste
Rti Surgical, Inc.
007875
In Commercial Distribution

  • 00854095006450 ()
007875

  • Bone matrix implant, human-derived
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