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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™ Penicillium notatum - 00630414965031

Penicillium notatum -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386019
In Commercial Distribution

  • 00630414965031 ()
M1L4

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

IMMULITE® 2000 Systems 3gAllergy™ Rhizopus nigricans - 00630414965024

Rhizopus nigricans -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386012
In Commercial Distribution

  • 00630414965024 ()
M11L2

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

IMMULITE®2000 Systems 3gAllergy™ Latex - 00630414960876

Latex-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385996
In Commercial Distribution

  • 00630414960876 ()
K82L4

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

IMMULITE®2000 Systems 3gAllergy™ Cockroach - 00630414960722

Cockroach-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385959
In Commercial Distribution

  • 00630414960722 ()
I6L2

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

IMMULITE®2000 Systems 3gAllergy™ Paper Wasp Venom - 00630414960715

Paper Wasp Venom -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385957
In Commercial Distribution

  • 00630414960715 ()
I4L2

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

IMMULITE®2000 Systems 3gAllergy™ Yellow Jacket Venom - 00630414960708

Yellow Jacket Venom -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385956
In Commercial Distribution

  • 00630414960708 ()
I3L2

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

IMMULITE®2000 Systems 3gAllergy™ White Faced Hornet - 00630414960692

White Faced Hornet -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385955
In Commercial Distribution

  • 00630414960692 ()
I2L2

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

IMMULITE®2000 Systems 3gAllergy™ Honey Bee Venom - 00630414960685

Honey Bee Venom -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385950
In Commercial Distribution

  • 00630414960685 ()
I1L4

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

IMMULITE®2000 Systems 3gAllergy™ House Dust Panel 1 - 00630414960678

Dust Panel 1 - IMMULITE - RGT - 40 test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385948
In Commercial Distribution

  • 00630414960678 ()
HP1L4

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

IMMULITE®2000 Systems 3gAllergy™ House Dust-Bencard - 00630414960661

House Dust#Bencard -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385943
In Commercial Distribution

  • 00630414960661 ()
H3L2

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