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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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QC Sets and Panels: Helix Elite™ Enteric Parasite Verification Panel (Synthetic)
MICROBIOLOGICS INC.
8182
Not in Commercial Distribution

  • 70845357041356 ()
8182

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Enteric Viral Control Panel
MICROBIOLOGICS INC.
8211
In Commercial Distribution

  • 70845357041158 ()
8211

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Enteric Viral Verification Panel
MICROBIOLOGICS INC.
8210
In Commercial Distribution

  • 70845357041141 ()
8210

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
BD MAX™ Enteric Parasite 20-Day QC Panel
MICROBIOLOGICS INC.
8202 BD MAX™ Enteric Parasite 20-Day QC Panel
In Commercial Distribution

  • 70845357041097 ()
8202

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
425089
In Commercial Distribution

  • 00815381020963 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0104
In Commercial Distribution

  • 00815381020116 ()
RFIT-ASY-0104

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0116
In Commercial Distribution

  • 00815381020109 ()
RFIT-ASY-0116

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
424898
In Commercial Distribution

  • 00815381020888 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Xpert Norovirus kit; 10 test kit
CEPHEID
GXNOV-10
In Commercial Distribution

  • 07332940000974 ()
GXNOV-10

  • 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
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