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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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IMMULITE® 2000 Systems 3gAllergy™ Phoma betae - 00630414995953

Phoma betae -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386014
In Commercial Distribution

  • 00630414995953 ()
M13L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

IMMULITE®2000 Systems 3gAllergy™ Epicoccum purpurascens - 00630414995946

Epicoccum purpurascens -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386015
In Commercial Distribution

  • 00630414995946 ()
M14L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

IMMULITE®2000 Systems 3gAllergy™ Trichoderma viride - 00630414995939

Trichoderma viride -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386016
In Commercial Distribution

  • 00630414995939 ()
M15L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

IMMULITE®2000 Systems 3gAllergy™ Curvularia lunata - 00630414995922

Curvularia lunata -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386017
In Commercial Distribution

  • 00630414995922 ()
M16L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

IMMULITE®2000 Systems 3gAllergy™ Cephalosporium acremonium - 00630414995915

Cephalsporium acremonium-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386020
In Commercial Distribution

  • 00630414995915 ()
M202L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

IMMULITE®2000 Systems 3gAllergy™ Fusarium moniliforme - 00630414995892

Fusarium moniliforme -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386046
In Commercial Distribution

  • 00630414995892 ()
M9L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

IMMULITE®2000 Systems 3gAllergy™ Mesquite - 00630414995885

Mesquite -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386070
In Commercial Distribution

  • 00630414995885 ()
T20L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

IMMULITE®2000 Systems 3gAllergy™ Red Cedar - 00630414995878

Red Cedar -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386074
In Commercial Distribution

  • 00630414995878 ()
T219L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

IMMULITE®2000 Systems 3gAllergy™ Melaleuca - 00630414995861

Melaleuca -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386075
In Commercial Distribution

  • 00630414995861 ()
T21L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

IMMULITE®2000 Systems 3gAllergy™ Australian Pine - 00630414995847

Australian Pine -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386104
In Commercial Distribution

  • 00630414995847 ()
T73L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
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