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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™ Pityrosporum orbiculare - 00630414965949

Pityrosporum orbiculare -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386043
In Commercial Distribution

  • 00630414965949 ()
M70L2

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

IMMULITE® 2000 Systems 3gAllergy™ Mucor racemosus - 00630414965932

Mucor racemosus -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386038
In Commercial Distribution

  • 00630414965932 ()
M4L2

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

IMMULITE®2000 Systems 3gAllergy™ Aspergillus niger - 00630414965925

Aspergillus -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386023
In Commercial Distribution

  • 00630414965925 ()
M207L2

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

IMMULITE®2000 Systems 3gAllergy™ Imported Fire Ant - 00630414965680

Imported Fire Ant -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385960
In Commercial Distribution

  • 00630414965680 ()
I70L2

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

IMMULITE®2000 Systems 3gAllergy™ Yellow Hornet - 00630414965673

Yellow Hornet -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385958
In Commercial Distribution

  • 00630414965673 ()
I5L2

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

IMMULITE®2000 Systems 3gAllergy™ Cheddar Cheese - 00630414965659

Cheese, Cheddar -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385858
In Commercial Distribution

  • 00630414965659 ()
F81L2

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

IMMULITE® 2000 Systems 3gAllergy™ Barley - 00630414965642

Barley -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385845
In Commercial Distribution

  • 00630414965642 ()
F6L2

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

IMMULITE®2000 Systems 3gAllergy™ Tuna - 00630414965635

Tuna -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385824
In Commercial Distribution

  • 00630414965635 ()
F40L2

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

IMMULITE®2000 Systems 3gAllergy™ Blue Mussel - 00630414965628

Blue Mussel -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385812
In Commercial Distribution

  • 00630414965628 ()
F37L2

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

IMMULITE®2000 Systems 3gAllergy™ Duck Feathers - 00630414965604

Duck Feathers -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385671
In Commercial Distribution

  • 00630414965604 ()
E86L2

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