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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
999-60601
Not in Commercial Distribution

  • 00856626006205 ()
999-60601

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, reagent
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
997-60901
Not in Commercial Distribution

  • 00856626006168 ()
997-60901

  • Alpha-fetoprotein-L3 fraction (AFP-L3) IVD, calibrator
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-60701
Not in Commercial Distribution

  • 00856626006120 ()
995-60701

  • Des-gamma-carboxyprothrombin (DCP) IVD, reagent
In-Vitro Diagnostic Use
FUJIFILM WAKO PURE CHEMICAL CORPORATION
995-40801
Not in Commercial Distribution

  • 00856626006113 ()
995-40801

  • Total complement activity (CH50) IVD, reagent
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)
Antisperm Antibody Quality Control for semen analysis. Contains 8 vials of human sera, 4 positive and 4 negative for IgG antisperm antibodies. Each vial contains 500 µL. https://www.fertilitysolutions.com/product-category/antisperm-antibody-quality-control
Fertility Solutions, Inc.
AQC109
In Commercial Distribution

  • 00860010518175 ()

  • 500 microliters per vial
AQC109

  • Sperm antibody IVD, control
Validate GC1ri is intended for the quantitative determination of Calibration Verification/Linearity of general chemistries on automated instruments.
Lgc Clinical Diagnostics, Inc.
1100ri
In Commercial Distribution

  • 00859110005227 ()

  • 2 tests
1100ri

  • Multiple-type clinical chemistry analyte profile IVD, control
Validate GC1bc is intended for the quantitative determination of Calibration Verification/Linearity of general chemistries on automated instruments.
Lgc Clinical Diagnostics, Inc.
1100bc
In Commercial Distribution

  • 00859110005203 ()

  • 2 tests
1100bc

  • Multiple-type clinical chemistry analyte profile IVD, control
Validate GC1ab is intended for the quantitative determination of Calibration Verification/Linearity of general chemistries on automated instruments.
Lgc Clinical Diagnostics, Inc.
1100ab
In Commercial Distribution

  • 00859110005180 ()

  • 2 tests
1100ab

  • Multiple-type clinical chemistry analyte profile IVD, control
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