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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™ Locust Tree - 00630414978963

Locust Tree-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386081
In Commercial Distribution

  • 00630414978963 ()
T280L2

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

IMMULITE®2000 Systems 3gAllergy™ Red Maple - 00630414978956

Red Maple-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386080
In Commercial Distribution

  • 00630414978956 ()
T27L2

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

IMMULITE®2000 Systems 3gAllergy™ Pecan - 00630414978949

Pecan -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386077
In Commercial Distribution

  • 00630414978949 ()
T22L2

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

IMMULITE®2000 Systems 3gAllergy™ Bayberry/Sweet Gale - 00630414978932

Bayberry/Sweet Gale-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386073
In Commercial Distribution

  • 00630414978932 ()
T218L2

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

IMMULITE®2000 Systems 3gAllergy™ Sweet Gum - 00630414978925

Sweet Gum-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386072
In Commercial Distribution

  • 00630414978925 ()
T211L2

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

IMMULITE®2000 Systems 3gAllergy™ Live Oak Tree - 00630414978901

Live Oak -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386055
In Commercial Distribution

  • 00630414978901 ()
T103L2

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

IMMULITE®2000 Systems 3gAllergy™ Tabacco - 00630414978895

Tobacco-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386050
In Commercial Distribution

  • 00630414978895 ()
O201L2

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

IMMULITE®2000 Systems 3gAllergy™ Hormodendrum hordei - 00630414978888

Hormodendrum hordei-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386037
In Commercial Distribution

  • 00630414978888 ()
M45L2

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

IMMULITE®2000 Systems 3gAllergy™ Penicillium brevi-compactum - 00630414978833

Penicillium brevi-compactum-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386030
In Commercial Distribution

  • 00630414978833 ()
M305L2

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

IMMULITE®2000 Systems 3gAllergy™ Aureobasidium pullulans - 00630414978789

Aureobasidium pullulans -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386013
In Commercial Distribution

  • 00630414978789 ()
M12L2

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