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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™ Mushroom - 00630414959962

Mushroom-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385716
In Commercial Distribution

  • 00630414959962 ()
F212L2

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

IMMULITE®2000 Systems 3gAllergy™ Pistacchio - 00630414959955

Pistachio-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385707
In Commercial Distribution

  • 00630414959955 ()
F203L2

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

IMMULITE®2000 Systems 3gAllergy™ Egg White - 00630414959948

Egg White -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385704
In Commercial Distribution

  • 00630414959948 ()
F1L4

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

IMMULITE®2000 Systems 3gAllergy™ Hazelnut - 00630414959931

Hazelnut-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385699
In Commercial Distribution

  • 00630414959931 ()
F17L4

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

IMMULITE®2000 Systems 3gAllergy™ White Bean - 00630414959924

White Bean -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385696
In Commercial Distribution

  • 00630414959924 ()
F15L2

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

IMMULITE®2000 Systems 3gAllergy™ Soybean - 00630414959917

Soybean -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385695
In Commercial Distribution

  • 00630414959917 ()
F14L4

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

IMMULITE®2000 Systems 3gAllergy™ Peanut - 00630414959900

Peanut -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385692
In Commercial Distribution

  • 00630414959900 ()
F13L4

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

IMMULITE®2000 Systems 3gAllergy™ Sesame Seed - 00630414959894

Sesame Seed -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385687
In Commercial Distribution

  • 00630414959894 ()
F10L2

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

IMMULITE®2000 Systems 3gAllergy™ Chocolate - 00630414959887

Chocolate-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385686
In Commercial Distribution

  • 00630414959887 ()
F105L2

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

IMMULITE®2000 Systems 3gAllergy™ Animal Panel 1 - 00630414959856

Animal Panel 1 - IMMULITE - RGT - 40 test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385677
In Commercial Distribution

  • 00630414959856 ()
EP1L4

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