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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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A rapid test for the qualitative detection of Influenza A & B Antigens in nasal swab specimens.
Alere Scarborough, Inc.
412-000
Not in Commercial Distribution

  • 10811877010873 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
A rapid test for the qualitative detection of Influenza A & B antigens with NP swab and nasal swab specimens
Alere Scarborough, Inc.
575-000
Not in Commercial Distribution

  • 10811877010156 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
iotaSOFT Plus Drive Unit
Iotamotion, Inc.
IM-05
In Commercial Distribution

  • 00850002960068 ()


  • Robotic surgical system application software
iotaSOFT Control Console
Iotamotion, Inc.
IM-01
In Commercial Distribution

  • 00850002960051 ()


  • Robotic surgical system application software
iotaSOFT Rolling Stand
Iotamotion, Inc.
IM-04
In Commercial Distribution

  • 00850002960044 ()


  • Robotic surgical system application software
iotaSOFT Footpedal
Iotamotion, Inc.
IM-03
In Commercial Distribution

  • 00850002960037 ()


  • Robotic surgical system application software
iotaSOFT Console
Iotamotion, Inc.
IM-02
In Commercial Distribution

  • 00850002960020 ()


  • Robotic surgical system application software
iotaSOFT Drive Unit
Iotamotion, Inc.
IM-00
In Commercial Distribution

  • 00850002960006 ()


  • Robotic surgical system application software
Xpect Flu A&B KT/20TST
REMEL, INC.
R24600
In Commercial Distribution

  • 30848838027032 ()
  • 00848838027031 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical
An in vitro diagnostic test for the detection of influenza A and influenza B viral nucleoprotein antigens from nasopharyngeal secretion specimens in symptomatic patients.
NANO-DITECH CORPORATION
TF8147
In Commercial Distribution

  • 00895160002526 ()
  • 10895160002523 ()
TF8147

  • Influenza A/B virus antigen IVD, kit, fluorescent immunoassay
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