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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™ Mold Panel 1 - 00630414965086

Mold Panel 1 - IMMULITE - RGT - 40 test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386048
In Commercial Distribution

  • 00630414965086 ()
MP1L4

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

IMMULITE®2000 Systems 3gAllergy™ Alternaria tenuis - 00630414965079

Alternaria tenuis-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386042
In Commercial Distribution

  • 00630414965079 ()
M6L4

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

IMMULITE®2000 Systems 3gAllergy™ Candida albicans - 00630414965062

Candida albicans -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386040
In Commercial Distribution

  • 00630414965062 ()
M5L4

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

IMMULITE®2000 Systems 3gAllergy™ Aspergillus fumigatus - 00630414965055

Aspergillus fumigatus -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386036
In Commercial Distribution

  • 00630414965055 ()
M3L4

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

IMMULITE®2000 Systems 3gAllergy™ Cladosporium herbarum - 00630414965048

Cladosporium herbarum -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386027
In Commercial Distribution

  • 00630414965048 ()
M2L4

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

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
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