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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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iotaSOFT Insertion System - 00850002960044

iotaSOFT Rolling Stand
Iotamotion, Inc.
IM-04
In Commercial Distribution

  • 00850002960044 ()


  • Robotic surgical system application software

iotaSOFT Insertion System - 00850002960037

iotaSOFT Footpedal
Iotamotion, Inc.
IM-03
In Commercial Distribution

  • 00850002960037 ()


  • Robotic surgical system application software

iotaSOFT Insertion System - 00850002960020

iotaSOFT Console
Iotamotion, Inc.
IM-02
In Commercial Distribution

  • 00850002960020 ()


  • Robotic surgical system application software

iotaSOFT Insertion System - 00850002960006

iotaSOFT Drive Unit
Iotamotion, Inc.
IM-00
In Commercial Distribution

  • 00850002960006 ()


  • Robotic surgical system application software

Fluoro-CheckTM Influenza A+B - 00895160002526

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

ImmunoCard STAT! FLU A&B - 00840733101656

ImmunoCard STAT! Flu A&B is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly form nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Moderate Complexity when used with Nasal Wash/Aspirate Samples. CLIA Waived when used with Nasal and Nasopharyngeal Swabs.
MERIDIAN BIOSCIENCE, INC.
782030
In Commercial Distribution

  • 00840733101656 ()
782030

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

ImmunoCard STAT! FLU A&B Nasopharyngeal Wash/Aspriate Kit - 00840733101649

Nasopharyngeal Wash/Aspirate Kit for use with ImmunoCard STAT! FLU A&B. ImmunoCard STAT! Flu A&B is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly form nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. Moderate Complexity when used with Nasal Wash/Aspirate Samples.
MERIDIAN BIOSCIENCE, INC.
781130
In Commercial Distribution

  • 00840733101649 ()
781130

  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

BinaxNOW Influenza A & B Card 2 - 10811877010972

A rapid test for the qualitative detection of Influenza A & B antigens with NP swab and nasal swab specimens.
Alere Scarborough, Inc.
575-000
In Commercial Distribution

  • 10811877010972 ()


  • Influenza A/B virus antigen IVD, kit, rapid ICT, clinical

Alere Influenza A & B Test - 10811877010873

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

Alere BinaxNOW Influenza A & B Card 2 - 10811877010156

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
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