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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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Xpert FLU/RSV XC kit; 10 test kit
CEPHEID
GXFLU/RSV-10
In Commercial Distribution

  • 07332940000783 ()
GXFLU/RSV-10

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Solana RSV/hMPB Assay
DIAGNOSTIC HYBRIDS, INC.
M306
In Commercial Distribution

  • 30014613336143 ()
M306

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Solana Infulenza A+B Assay
DIAGNOSTIC HYBRIDS, INC.
M300
In Commercial Distribution

  • 30014613336068 ()
M300

  • Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Lyra Adenovirus Assay
QUIDEL CORPORATION
Adenovirus Assay
In Commercial Distribution

  • 30014613311133 ()
M113

  • Adenovirus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Biocartis NV
1.0
Not in Commercial Distribution

  • 15415219000635 ()
  • 05415219000638 ()
A1030/6

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Panther Fusion® Specimen Lysis Tubes.
Hologic, Inc.
SPECIMEN LYSIS TUBES, IVD
In Commercial Distribution

  • 15420045509238 ()
PRD-04339

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Hologic, Inc.
PROADENO+ KIT, 100 REACTIONS
Not in Commercial Distribution

  • 15420045506381 ()
303675

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Hologic, Inc.
PROFLU+ ASSAY KIT, 1,500 REACTIONS
Not in Commercial Distribution

  • 15420045506343 ()
303123

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Hologic, Inc.
PROFLU+ ASSAY KIT, 2,000 REACTIONS
Not in Commercial Distribution

  • 15420045506336 ()
303121

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Hologic, Inc.
PRODESSE PROFLU+ ASSAY
Not in Commercial Distribution

  • 15420045506329 ()
303111

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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