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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™ Oak - 00630414965284

Oak -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386107
In Commercial Distribution

  • 00630414965284 ()
T7L4

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

IMMULITE®2000 Systems 3gAllergy™ White Mulberry - 00630414965277

White Mulberry -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386101
In Commercial Distribution

  • 00630414965277 ()
T70L2

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

IMMULITE®2000 Systems 3gAllergy™ Mountain Cedar - 00630414965260

Mountain Cedar -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386100
In Commercial Distribution

  • 00630414965260 ()
T6L2

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

IMMULITE®2000 Systems 3gAllergy™ Beech - 00630414965253

Beech -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386098
In Commercial Distribution

  • 00630414965253 ()
T5L2

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

IMMULITE®2000 Systems 3gAllergy™ Hazelnut - 00630414965246

Hazelnut -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386097
In Commercial Distribution

  • 00630414965246 ()
T4L4

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

IMMULITE®2000 Systems 3gAllergy™ Birch - 00630414965239

Birch -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386087
In Commercial Distribution

  • 00630414965239 ()
T3L4

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

IMMULITE®2000 Systems 3gAllergy™ Alder - 00630414965222

Alder-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386083
In Commercial Distribution

  • 00630414965222 ()
T2L4

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

IMMULITE®2000 Systems 3gAllergy™ Maple - 00630414965215

Maple -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386066
In Commercial Distribution

  • 00630414965215 ()
T1L2

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

IMMULITE®2000 Systems 3gAllergy™ Acacia - 00630414965208

Acacia -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386065
In Commercial Distribution

  • 00630414965208 ()
T19L2

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

IMMULITE®2000 Systems 3gAllergy™ Japanse Cedar - 00630414965192

Japanese Cedar -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386063
In Commercial Distribution

  • 00630414965192 ()
T17L4

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

IMMULITE®2000 Systems 3gAllergy™ White Pine - 00630414965185

White Pine -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386061
In Commercial Distribution

  • 00630414965185 ()
T16L2

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

IMMULITE®2000 Systems 3gAllergy™ Cottonwood - 00630414965178

Cottonwood -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386059
In Commercial Distribution

  • 00630414965178 ()
T14L2

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

IMMULITE®2000 Systems 3gAllergy™ Willow - 00630414965161

Willow -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386058
In Commercial Distribution

  • 00630414965161 ()
T12L2

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

IMMULITE®2000 Systems 3gAllergy™ Sycamore - 00630414965154

Sycamore -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386057
In Commercial Distribution

  • 00630414965154 ()
T11L2

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

IMMULITE®2000 Systems 3gAllergy™ Walnut - 00630414965147

Walnut -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386056
In Commercial Distribution

  • 00630414965147 ()
T10L2

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

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

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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