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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™ Green Bean - 00630414973272

Green Bean-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385794
In Commercial Distribution

  • 00630414973272 ()
F315L2

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

IMMULITE®2000 Systems 3gAllergy™ Cherry - 00630414973265

Cherry-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385740
In Commercial Distribution

  • 00630414973265 ()
F242L2

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

IMMULITE®2000 Systems 3gAllergy™ Plum - 00630414973241

Plum-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385748
In Commercial Distribution

  • 00630414973241 ()
F255L2

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

IMMULITE®2000 Systems 3gAllergy™ Pork - 00630414973234

Pork -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385761
In Commercial Distribution

  • 00630414973234 ()
F26L2

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

IMMULITE®2000 Systems 3gAllergy™ Turkey Meat - 00630414973227

Turkey Meat-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385774
In Commercial Distribution

  • 00630414973227 ()
F284L2

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

IMMULITE®2000 Systems 3gAllergy™ Red Kidney Bean - 00630414973210

Red Kidney Bean-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385775
In Commercial Distribution

  • 00630414973210 ()
F287L2

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

IMMULITE®2000 Systems 3gAllergy™ Blueberry - 00630414973203

Blueberry-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385776
In Commercial Distribution

  • 00630414973203 ()
F288L2

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

IMMULITE®2000 Systems 3gAllergy™ Oyster - 00630414973197

Oyster-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385778
In Commercial Distribution

  • 00630414973197 ()
F290L2

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

IMMULITE®2000 Systems 3gAllergy™ Crab - 00630414973180

Crab -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385739
In Commercial Distribution

  • 00630414973180 ()
F23L2

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

IMMULITE® 2000 Systems Diluent Tubes - 00630414973159

No Description
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10385210
In Commercial Distribution

  • 00630414973159 ()
L2ZT

  • General specimen container IVD, no additive/medium

IMMULITE®2000 Systems 3gAllergy™ Sunflower - 00630414972947

Sunflower-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385998
In Commercial Distribution

  • 00630414972947 ()
K84L2

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

IMMULITE®2000 Systems Diluent Tube Caps - 00630414972923

No Description
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10385211
In Commercial Distribution

  • 00630414972923 ()
L2ZC

  • General specimen container IVD, no additive/medium

IMMULITE® 2000 Systems SBG SHBG - 00630414972916

SHBG - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381198
In Commercial Distribution

  • 00630414972916 ()
L2KSH2

  • Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay

IMMULITE® Systems SHBG DIL SHBG - 00630414972831

SHBG Diluent - IMMULITE - CAL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385366
In Commercial Distribution

  • 00630414972831 ()
L1KSHW1

  • Buffered sample diluent IVD

IMMULITE®2000 Systems 3gAllergy™ American Cockroach - 00630414972800

American Cockroach-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385953
In Commercial Distribution

  • 00630414972800 ()
I206L2

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

IMMULITE®2000 Systems 3gAllergy™ Red Snapper - 00630414972619

Red Snapper-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385813
In Commercial Distribution

  • 00630414972619 ()
F381L2

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

IMMULITE®2000 Systems 3gAllergy™ Yogurt - 00630414972602

Yogurt-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385810
In Commercial Distribution

  • 00630414972602 ()
F360L2

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

IMMULITE®2000 Systems 3gAllergy™ Lime - 00630414972527

Lime-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385789
In Commercial Distribution

  • 00630414972527 ()
F306L2

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

IMMULITE®2000 Systems 3gAllergy™ Oregano - 00630414972503

Oregano-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385773
In Commercial Distribution

  • 00630414972503 ()
F283L2

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

IMMULITE® Systems E2 Calibration Verification Material Estradiol - 00630414971216

Estradiol CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373688
In Commercial Distribution

  • 00630414971216 ()
LE2CVM

  • Estradiol (oestradiol) (E2) IVD, control

IMMULITE®2000 Systems 3gAllergy™ Stemphylium solani - 00630414970691

Stemphylium solani-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10360577
In Commercial Distribution

  • 00630414970691 ()
M88L2

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

IMMULITE®2000 Systems 3gAllergy™ nFel d 1 - 00630414970684

Felis domesticus-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10360576
In Commercial Distribution

  • 00630414970684 ()
A345L2

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

IMMULITE®2000 Systems 3gAllergy™ nDer p 2 - 00630414970677

Dermatophagoides pteronyssinus-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10360575
In Commercial Distribution

  • 00630414970677 ()
A316L2

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

IMMULITE®2000 Systems 3gAllergy™ nDer p 1 - 00630414970660

Dermatophagoides pteronyssinus-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10360574
In Commercial Distribution

  • 00630414970660 ()
A310L2

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

IMMULITE®2000 Systems 3gAllergy™ nAsp r 1 - 00630414970653

Aspergillus restrictus-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10360573
In Commercial Distribution

  • 00630414970653 ()
A3050L2

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

IMMULITE®2000 Systems 3gAllergy™ nDer f 2 - 00630414970646

Dermatophagoides farinae-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10360572
In Commercial Distribution

  • 00630414970646 ()
A302L2

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

IMMULITE®2000 Systems 3gAllergy™ nDer f 1 - 00630414970639

Dermatophagoides farinae-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10360571
In Commercial Distribution

  • 00630414970639 ()
A295L2

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

IMMULITE®2000 Systems 3gAllergy™ nCan f 1 - 00630414970622

Canis familiaris-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10360570
In Commercial Distribution

  • 00630414970622 ()
A174L2

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

IMMULITE®2000 Systems 3gAllergy™ Rabbit Epithelium - 00630414969343

Rabbit Epithelium-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385667
In Commercial Distribution

  • 00630414969343 ()
E82L4

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

IMMULITE®/IMMULITE® 1000 Systems SBG SHBG - 00630414966557

SHBG - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381138
In Commercial Distribution

  • 00630414966557 ()
LKSH1

  • Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassay
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