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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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BD Veritor™ System CLIA-Waived Combo Pack Contains: 2xBD Veritor ™ System for Rapid Detection of Flu A+B, CLIA-Wavied Kits (Cat. No. 256045) 1xBD Veritor ™ System Reader (Cat. No. 256055)
BECTON, DICKINSON AND COMPANY
256071
Not in Commercial Distribution

  • 00382902560715 ()
256071

  • Multiple-genus respiratory virus antigen IVD, kit, rapid ICT, clinical
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
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
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
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
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