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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.
402
In Commercial Distribution

  • 06972677874038 ()
  • 06972677874021 ()


  • Gold dental inlay
  • Dental casting noble alloy
  • Custom-made dental crown, metal
  • Complete upper denture
  • Complete lower denture
  • Dental bridge, metal-ceramic
  • Custom-made dental crown, metal/ceramic
  • Custom-made dental crown, ceramic
  • Dental bridge, ceramic
  • Ceramic dental inlay
  • Dental veneer, professional
No Description
Modern Dental Laboratory (DG) Co., Ltd.
350
In Commercial Distribution

  • 06972677873512 ()
  • 06972677873505 ()


  • Custom-made dental crown, metal
  • Dental casting noble alloy
  • Gold dental inlay
  • 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
No Description
Modern Dental Laboratory (DG) Co., Ltd.
314
In Commercial Distribution

  • 06972677873154 ()
  • 06972677873147 ()


  • Dental casting noble alloy
  • Custom-made dental crown, metal
  • Gold dental inlay
  • Custom-made dental crown, ceramic
  • Dental bridge, ceramic
  • Ceramic dental inlay
  • Dental veneer, professional
  • Removable dental occlusal splint, preformed
  • Orthodontic appliance system, bonded
  • Orthodontic retainer
ABBOTT PRISM Prime/Purge Accessories
ABBOTT LABORATORIES
7A03-01
Not in Commercial Distribution

  • 00380740027056 ()
07A0301

  • Buffered wash solution IVD
Intended to be used for the qualitative detection of RNA from SARS-CoV-2 Low profile 96 well PCR plated assay and optical film for use on Roche LightCycler 11 instrument .
GENEDRIVE DIAGNOSTICS LTD
1
In Commercial Distribution

  • 05060654860059 ()
  • 05060654860134 ()
ID-CoV2-01-LPU

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
Vista COV2T Assay
Siemens Healthcare Diagnostics Inc.
11417414
Not in Commercial Distribution

  • 00630414297613 ()
  • 00630414605500 ()
K7414

  • SARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay
Dimension CV2T Assay
Siemens Healthcare Diagnostics Inc.
11417412
Not in Commercial Distribution

  • 00630414297590 ()
  • 00630414605418 ()
RF812

  • SARS-CoV-2 total antibody IVD, kit, chemiluminescent immunoassay
Intended to be used for the qualitative detection of RNA from SARS-CoV-2 Fast- profile 96 well PCR plated assay and optical film for use on ABI 7500 Fast instrument .
GENEDRIVE DIAGNOSTICS LTD
1
In Commercial Distribution

  • 05060654860127 ()
  • 05060654860080 ()
ID-CoV2-01-FPU

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
Intended to be used for the qualitative detection of RNA from SARS-CoV-2 Low profile 96 well PCR plated assay and optical film for use on Biorad CFX96 instrument.
GENEDRIVE DIAGNOSTICS LTD
1
In Commercial Distribution

  • 05060654860103 ()
  • 05060654860110 ()
ID-CoV2-01-BPU

  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
EUA
INBIOS INTERNATIONAL, INC
COV2-E
In Commercial Distribution

  • B379COV2E0 ()


  • SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT)
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