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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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In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
999-00404
In Commercial Distribution

  • 04987481164536 ()
  • 14987481164533 ()
999-00404

  • Low density lipoprotein (LDL) cholesterol IVD, reagent
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
991-61401
In Commercial Distribution

  • 04987481164499 ()
  • 14987481164496 ()
  • 10856626006066 ()
991-61401

  • Des-gamma-carboxyprothrombin (DCP) IVD, control
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-61301
In Commercial Distribution

  • 04987481164482 ()
  • 14987481164489 ()
  • 10856626006134 ()
995-61301

  • Des-gamma-carboxyprothrombin (DCP) IVD, control
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
997-61501
In Commercial Distribution

  • 04987481164468 ()
  • 14987481164465 ()
  • 10856626006189 ()
997-61501

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, kit, fluorescent immunoassay
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
993-61101
In Commercial Distribution

  • 04987481164451 ()
  • 14987481164458 ()
  • 10856626006073 ()
993-61101

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, control
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
997-61001
In Commercial Distribution

  • 04987481164444 ()
  • 14987481164441 ()
  • 10856626006172 ()
997-61001

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, control
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
464-01601
In Commercial Distribution

  • 04987481102927 ()
  • 14987481102924 ()
  • 10856626006028 ()
464-01601

  • Triglyceride IVD, calibrator
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
276-76491
In Commercial Distribution

  • 04987481100992 ()
  • 14987481100999 ()
  • 10856626006011 ()
276-76491

  • Non-esterified fatty acid IVD, calibrator
In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of respiratory pathogens.
APPLIED BIOCODE, INC.
01
In Commercial Distribution

  • 00851034007073 ()
63-R0001

  • Multiple-type respiratory pathogen nucleic acid IVD, control
In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of gastrointestinal pathogens.
APPLIED BIOCODE, INC.
1
In Commercial Distribution

  • 00851034007011 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
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