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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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BioCode MDx 3000 Optical Calibration and Verification Kit - 00851034007028

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

Gastrointestinal Pathogen Panel (GPP) Kit - 00851034007011

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)

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)

BIOFIRE® FILMARRAY® Gastrointestinal (GI) Panel Mid - 00815381020888

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)

FilmArray® Gastrointestinal (GI) Panel - 00815381020116

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)

FilmArray® Gastrointestinal (GI) Panel - 00815381020109

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)

Helix Elite™ Molecular Standards: Inactivated Standard - 10845357042016

Helix Elite™ Molecular Standards Inactivated Rotavirus Strain Simian SA-11
MICROBIOLOGICS INC.
HE0027N
In Commercial Distribution

  • 10845357042016 ()
HE0027N

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

Helix Elite™ Molecular Standards: Synthetic Standard - 10845357041965

Helix Elite™ Molecular Standards Cyclospora cayetanensis Synthetic DNA
MICROBIOLOGICS INC.
HE0025S
Not in Commercial Distribution

  • 10845357041965 ()
HE0025S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

Helix Elite™ Molecular Standards: Synthetic Standard - 10845357041774

Helix Elite™ Molecular Standards Giardia lamblia Synthetic DNA
MICROBIOLOGICS INC.
HE0005S
Not in Commercial Distribution

  • 10845357041774 ()
HE0005S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

Helix Elite™ Molecular Standards: Synthetic Standard - 10845357041767

Helix Elite™ Molecular Standards Encephalitozoon intestinalis Synthetic DNA
MICROBIOLOGICS INC.
HE0004S
Not in Commercial Distribution

  • 10845357041767 ()
HE0004S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
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