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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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Axilum Robotics TMS-Cobot TS MV
AXILUM ROBOTICS
TMS-Cobot-2
In Commercial Distribution

  • 03701354620117 ()
2-01-01

  • Magnetic neural stimulation system
Axilum Robotics TMS-Cobot TS MV
AXILUM ROBOTICS
TMS-Cobot-2
Not in Commercial Distribution

  • 03701354600058 ()
2-01-02

  • Magnetic neural stimulation system
Coil adaptation kit for MagVenture Cool-B65-CO coil, for TMS-Cobot TS MV
AXILUM ROBOTICS
ADAP-MAGV-CB65A-12
Not in Commercial Distribution

  • 03701354600034 ()
2-02-18

  • Magnetic neural stimulation system
Microplasty Tibial Template Left Medial
Biomet Uk Ltd
32-422852
In Commercial Distribution

  • 05019279403844 ()

  • A
32-422852

  • Surgical implant template, reusable
Microplasty Tibial Template Right Medial
Biomet Uk Ltd
32-422851
In Commercial Distribution

  • 05019279403837 ()

  • A
32-422851

  • Surgical implant template, reusable
Tubigrip A Natural x 10m
Mölnlycke Health Care AB
1435
In Commercial Distribution

  • 07332551947873 ()
  • 07332551449384 ()
  • 07332551449391 ()

  • A


  • Tubular support bandage, Hevea-latex
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
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
Control Swabs ntended for use only with BinaxNOW™ Influenza A & B 2 Card product.
Alere Scarborough, Inc.
575-080
In Commercial Distribution

  • 10811877010989 ()


  • Influenza A/B virus antigen IVD, control
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