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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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Remel - 00848838058233

RapID YEAST PLUS System KT/20TST
REMEL, INC.
R8311007
In Commercial Distribution

  • 30848838058234 ()
  • 00848838058233 ()


  • Multiple Candida/yeast species culture isolate identification IVD, kit

Remel - 00848838058196

RapID ONE System 20/KT
REMEL, INC.
R8311006
In Commercial Distribution

  • 30848838058197 ()
  • 00848838058196 ()


  • Multiple Enterobacteriaceae species culture isolate identification IVD, kit

Remel - 00848838058110

RapID SS/u System KT/20
REMEL, INC.
R8311004
In Commercial Distribution

  • 30848838058111 ()
  • 00848838058110 ()


  • Multiple urinary tract pathogen culture isolate identification IVD, kit, rapid

Remel - 00848838058073

RapID STR System KT/20
REMEL, INC.
R8311003
In Commercial Distribution

  • 30848838058074 ()
  • 00848838058073 ()


  • Multiple Streptococcus bacterial species culture isolate identification IVD, kit

Remel - 00848838058035

RapID ANA II System 20/KT
REMEL, INC.
R8311002
In Commercial Distribution

  • 30848838058036 ()
  • 00848838058035 ()


  • Multiple anaerobic bacteria species culture isolate identification IVD, kit

Remel Inc - 00848838057991

RapID NH System KT/20
REMEL, INC.
R8311001
In Commercial Distribution

  • 00848838057991 ()
  • 30848838057992 ()


  • Multiple Haemophilus/Neisseria bacteria species culture isolate identification IVD, kit

REMEL - 00848838057953

Oxichrome Reagent 15ml/VL
REMEL, INC.
R8309009
In Commercial Distribution

  • 00848838057953 ()
R8309009

  • Bacterial species differentiation disc IVD

REMEL - 00848838057915

RapID Nitrate B Reagent 15ml/VL
REMEL, INC.
R8309004
In Commercial Distribution

  • 00848838057915 ()
R8309004

  • Nitrate reduction microbial reagent IVD

REMEL - 00848838057878

RapID Nitrate A Reagent 15ml/VL
REMEL, INC.
R8309003
In Commercial Distribution

  • 00848838057878 ()
R8309003

  • Nitrate reduction microbial reagent IVD

REMEL - 00848838057830

RapID Spot Indole Reagent 15ml/VL
REMEL, INC.
R8309002
In Commercial Distribution

  • 00848838057830 ()
R8309002

  • Bacterial species differentiation disc IVD
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