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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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No Description
Modern Dental Laboratory (DG) Co., Ltd.
326
In Commercial Distribution

  • 06972677873277 ()
  • 06972677873260 ()


  • Complete upper denture
  • Complete lower denture
  • Custom-made dental crown, metal/polymer
  • Custom-made dental crown, polymer
  • Dental bridge, metal-polymer
  • Dental bridge, polymer
  • Dental veneer, professional
  • Resin dental inlay
  • Dental bridge, metal-ceramic
  • Custom-made dental crown, metal/ceramic
No Description
ACESO DENTAL LABORATORY COMPANY LIMITED
500
In Commercial Distribution

  • 08936214225019 ()
  • 08936214225002 ()


  • Complete upper denture
  • Dental casting noble alloy
  • Custom-made dental crown, metal
  • Gold dental inlay
  • Partial denture
  • Complete lower denture
  • Dental bridge, metal-ceramic
  • Custom-made dental crown, metal/ceramic
  • Custom-made dental crown, ceramic
  • Dental bridge, ceramic
  • Dental veneer, professional
  • Ceramic dental inlay
No Description
Modern Dental Laboratory (DG) Co., Ltd.
500
In Commercial Distribution

  • 06972677875011 ()
  • 06972677875004 ()


  • Partial denture
  • Dental casting noble alloy
  • Custom-made dental crown, metal
  • Gold dental inlay
  • Complete upper denture
  • Complete lower denture
  • Dental bridge, metal-ceramic
  • Dental veneer, professional
  • Custom-made dental crown, metal/ceramic
  • Custom-made dental crown, ceramic
  • Dental bridge, ceramic
  • Ceramic dental inlay
OSOM COVID-19 Antigen Rapid Test
SEKISUI DIAGNOSTICS, LLC
1066-40
In Commercial Distribution

  • 00742860000027 ()
  • 10742860000024 ()
1066-40

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
No Description
PHASE SCIENTIFIC INTERNATIONAL LIMITED
25-Test
In Commercial Distribution

  • 04897116730985 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
An in vitro diagnostic lateral flow immunoassay for the qualitative detection of nucleocapsid antigen from SARS-CoV-2.
NANO-DITECH CORPORATION
MD-8147
In Commercial Distribution

  • 10895160002868 ()
  • 00895160002861 ()
MD-8147 2T

  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
An in vitro diagnostic test for the detection of anti-Dengue IgM and/or IgG in human whole blood of dengue infected patient from acute to convalescent stage.
NANO-DITECH CORPORATION
MD8144
In Commercial Distribution

  • 00895160002489 ()
  • 10895160002486 ()
MD8144

  • Dengue virus immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, rapid ICT, clinical
A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens
Alere Scarborough, Inc.
195-200
In Commercial Distribution

  • 10811877011337 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
No Description
WatMIND USA
RDB10-BIO-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (1 Test/Box)
In Commercial Distribution

  • 10810172700090 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
No Description
WatMIND USA
RDB6-SAN-Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (2 Tests/Box)
In Commercial Distribution

  • 10810172700083 ()


  • SARS-CoV-2 antigen IVD, kit, rapid ICT, clinical
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