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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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Ammonium Hydroxide Concentrated BTL/25ml
REMEL, INC.
R21195
Not in Commercial Distribution

  • 00848838023132 ()
R21195

  • Culture medium base ingredient IVD
Gram-Sure 25Disk/VL
REMEL, INC.
R211820
In Commercial Distribution

  • 00848838023125 ()
R211820

  • Bacterial species differentiation disc IVD
Nitrocefin Disk 25Disk/VL
REMEL, INC.
R211667
In Commercial Distribution

  • 00848838023088 ()
R211667

  • Bacterial species differentiation disc IVD
Vancomycin Disk 5mcg 25Disk/PK
REMEL, INC.
R21156
In Commercial Distribution

  • 00848838023064 ()
R21156

  • Bacterial species differentiation disc IVD
Urea-PDA Disk 25Disk/PK
REMEL, INC.
R21152
In Commercial Distribution

  • 00848838023040 ()
R21152

  • Bacterial species differentiation disc IVD
BactiStaph Latex 150TST/KT
REMEL, INC.
R21144
In Commercial Distribution

  • 30848838023003 ()
  • 00848838023002 ()


  • Staphylococcus aureus culture isolate antigen IVD, kit, agglutination
BactiStaph Latex 450TST/KT
REMEL, INC.
R21143
In Commercial Distribution

  • 30848838022983 ()
  • 00848838022982 ()


  • Staphylococcus aureus culture isolate antigen IVD, kit, agglutination
SPS Disk 25Disk/VL
REMEL, INC.
R21140
In Commercial Distribution

  • 00848838022968 ()
R21140

  • Bacterial species differentiation disc IVD
PYR/Esculin Disk 25Disk/VL
REMEL, INC.
R21138
In Commercial Distribution

  • 00848838022920 ()
R21138

  • Bacterial species differentiation disc IVD
Pyridoxal Disk 25Disk/VL
REMEL, INC.
R21137
In Commercial Distribution

  • 00848838022906 ()
R21137

  • Bacterial species differentiation disc IVD
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