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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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Helix Elite™ Molecular Standards: Synthetic Standard - 10845357041873

Helix Elite™ Molecular Standards Dientamoeba fragilis Synthetic DNA
MICROBIOLOGICS INC.
HE0015S
Not in Commercial Distribution

  • 10845357041873 ()
HE0015S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

Helix Elite™ Molecular Standards: Synthetic Standard - 10845357041859

Helix Elite™ Molecular Standards Norovirus GI.1 Synthetic RNA
MICROBIOLOGICS INC.
HE0013S
In Commercial Distribution

  • 10845357041859 ()
HE0013S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

Helix Elite™ Molecular Standards: Synthetic Standard - 10845357041842

Helix Elite™ Molecular Standards Norovirus GII.4 Synthetic RNA
MICROBIOLOGICS INC.
HE0012S
In Commercial Distribution

  • 10845357041842 ()
HE0012S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

Helix Elite™ Molecular Standards: Synthetic Standard - 10845357041798

Helix Elite™ Molecular Standards Entamoeba dispar Synthetic DNA
MICROBIOLOGICS INC.
HE0007S
Not in Commercial Distribution

  • 10845357041798 ()
HE0007S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

Helix Elite™ Molecular Standards: Synthetic Standard - 10845357041781

Helix Elite™ Molecular Standards Entamoeba histolytica Synthetic DNA
MICROBIOLOGICS INC.
HE0006S
Not in Commercial Distribution

  • 10845357041781 ()
HE0006S

  • 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

Helix Elite™ Molecular Standards: Synthetic Standard - 10845357041750

Helix Elite™ Molecular Standards Enterocytozoon bieneusi Synthetic DNA
MICROBIOLOGICS INC.
HE0003S
Not in Commercial Distribution

  • 10845357041750 ()
HE0003S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

Helix Elite™ Molecular Standards: Synthetic Standard - 10845357041743

Helix Elite™ Molecular Standards Cryptosporidium parvum Synthetic DNA
MICROBIOLOGICS INC.
HE0002S
Not in Commercial Distribution

  • 10845357041743 ()
HE0002S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control

Helix Elite™ Molecular Standards: Synthetic Standard - 10845357041736

Helix Elite™ Molecular Standards Cryptosporidium hominis Synthetic DNA
MICROBIOLOGICS INC.
HE0001S
Not in Commercial Distribution

  • 10845357041736 ()
HE0001S

  • Multiple-type gastrointestinal pathogen nucleic acid IVD, control
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