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™ Molecular Standards Bacterial vaginosis (BV) Control Panel
MICROBIOLOGICS INC.
8249
In Commercial Distribution

  • 70845357043732 ()
8249

  • Multiple vaginitis/vaginosis-associated pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Flu/RSV/SARS-CoV-2 Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8246
In Commercial Distribution

  • 70845357043602 ()
8246

  • Multiple-genus respiratory virus nucleic acid IVD, control
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™ Respiratory (4 Targets) Control Panel (Inactivated Swab)
MICROBIOLOGICS INC.
8233
Not in Commercial Distribution

  • 70845357042742 ()
8233

  • Multiple-type respiratory pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Comprehensive Enteric Bacterial Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8231
In Commercial Distribution

  • 70845357042704 ()
8231

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ CT/GC/TV Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8228
In Commercial Distribution

  • 70845357042681 ()
8228

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Blood Culture Identification (BCID) Verification Panel (Inactivated)
MICROBIOLOGICS INC.
8201
Not in Commercial Distribution

  • 70845357041486 ()
8201

  • Multiple-type bloodstream pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Gram-Negative Blood Culture Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8181
In Commercial Distribution

  • 70845357041431 ()
8181

  • Multiple-type bloodstream pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Gram-Positive Blood Culture Control Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8180
In Commercial Distribution

  • 70845357041424 ()
8180

  • Multiple-type bloodstream pathogen nucleic acid IVD, control
QC Sets and Panels: Helix Elite™ Extended Enteric Bacterial Verification Panel (Inactivated Pellet)
MICROBIOLOGICS INC.
8191
In Commercial Distribution

  • 70845357041363 ()
8191

  • Multiple-genus gastrointestinal disease-associated bacteria nucleic acid IVD, control
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