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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™ - 70845357043060

QC Sets and Panels: Helix Elite™ Gastrointestinal (22 Targets) Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8236
In Commercial Distribution

  • 70845357043060 ()
8236

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

QC Sets and Panels: Helix Elite™ - 70845357042698

QC Sets and Panels: Helix Elite™ Enteric Parasite Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8230
In Commercial Distribution

  • 70845357042698 ()
8230

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

QC Sets and Panels: Helix Elite™ - 70845357041448

QC Sets and Panels: Helix Elite™ Enteric Pathogens Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8184
In Commercial Distribution

  • 70845357041448 ()
8184

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

QC Sets and Panels: Helix Elite™ - 70845357041394

BD MAX™ Enteric Parasite Control Panel
MICROBIOLOGICS INC.
8204 BD MAX™ Enteric Parasite Control Panel
In Commercial Distribution

  • 70845357041394 ()
8204

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

QC Sets and Panels: Helix Elite™ - 70845357041356

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™ - 70845357041158

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™ - 70845357041141

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

QC Sets and Panels: Helix Elite™ - 70845357041097

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

Xpert Norovirus - 07332940000974

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)

BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid - 00815381020963

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)
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