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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™ Can f 3 - 00630414988153

Dog Serum Albumin, Can f 3-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10370456
In Commercial Distribution

  • 00630414988153 ()
E221L2

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

IMMULITE®2000 Systems 3gAllergy™ Fel d 2 - 00630414988146

Cat Serum Albumin, Fel d 2)-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10370455
In Commercial Distribution

  • 00630414988146 ()
E220L2

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

IMMULITE®2000 Systems 3gAllergy™ nBet v 1 - 00630414988122

Native Bet v 1-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10368597
In Commercial Distribution

  • 00630414988122 ()
A89L2

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

IMMULITE®2000 Systems 3gAllergy™ nOle e 1 - 00630414982915

Native Ole e 1-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10370467
In Commercial Distribution

  • 00630414982915 ()
A482L2

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

IMMULITE®2000 Systems 3gAllergy™ Saltbush - 00630414979182

Saltbush-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386153
In Commercial Distribution

  • 00630414979182 ()
W37L2

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

IMMULITE®2000 Systems 3gAllergy™ Firebush - 00630414979144

Firebush -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386138
In Commercial Distribution

  • 00630414979144 ()
W17L2

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

IMMULITE®2000 Systems 3gAllergy™ Rough Marsh Elder - 00630414979137

Rough Marsh Elder -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386137
In Commercial Distribution

  • 00630414979137 ()
W16L2

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

IMMULITE®2000 Systems 3gAllergy™ Scale - 00630414979120

Scale -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386136
In Commercial Distribution

  • 00630414979120 ()
W15L2

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

IMMULITE®2000 Systems 3gAllergy™ Rough Pigweed - 00630414979113

Rough Pigweed -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386135
In Commercial Distribution

  • 00630414979113 ()
W14L2

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

IMMULITE®2000 Systems 3gAllergy™ Goldenrod - 00630414979106

Goldenrod -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386133
In Commercial Distribution

  • 00630414979106 ()
W12L2

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