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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™ Lepidoglyphus destructor - 00630414975269

Lepidoglyphus destructor-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385636
In Commercial Distribution

  • 00630414975269 ()
D71L2

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

IMMULITE®2000 Systems 3gAllergy™ Tyrophagus putrescentiae - 00630414975252

Tyrophagus putrescentiae-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385637
In Commercial Distribution

  • 00630414975252 ()
D72L2

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

IMMULITE®2000 Systems 3gAllergy™ Glyceyphagus domesticus - 00630414975245

Glycyphagus domesticus-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385638
In Commercial Distribution

  • 00630414975245 ()
D73L2

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

IMMULITE®2000 Systems 3gAllergy™ Euroglyphus maynei - 00630414975238

Euroglyphus maynei-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385639
In Commercial Distribution

  • 00630414975238 ()
D74L2

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

IMMULITE®2000 Systems 3gAllergy™ Buckwheat - 00630414975146

Buckwheat -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385689
In Commercial Distribution

  • 00630414975146 ()
F11L2

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

IMMULITE®2000 Systems 3gAllergy™ Cashew - 00630414974422

Cashew-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385706
In Commercial Distribution

  • 00630414974422 ()
F202L2

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

IMMULITE® 1000 Systems1000 Sample Cup Caps - 00630414974194

No Description
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10385183
In Commercial Distribution

  • 00630414974194 ()
LSCC

  • General specimen container IVD, no additive/medium

IMMULITE®/IMMULITE® 1000 Systems SAMPLE CUPS - 00630414974187

IMMULITE Sample Cups(1000/pack) - IMMULITE - CONS - 1000 Pieces
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10380037
In Commercial Distribution

  • 00630414974187 ()
LSCP

  • General specimen container IVD, no additive/medium

IMMULITE®2000 Systems 3gAllergy™ Helminthosporium halodes - 00630414974118

Helminthosporium halodes -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386045
In Commercial Distribution

  • 00630414974118 ()
M8L2

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

IMMULITE® 1000 Systems E2 CONTROL Estradiol - 00630414974095

Estradiol - IMMULITE - CTL - 1x2.0mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10389765
In Commercial Distribution

  • 00630414974095 ()
E2TC1

  • Estradiol (oestradiol) (E2) IVD, control

IMMULITE® 2000 Systems Microsampling Tube Caps - 00630414974064

No Description
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10385205
In Commercial Distribution

  • 00630414974064 ()
LSMC

  • General specimen container IVD, no additive/medium

IMMULITE®2000 Systems 3gAllergy™ Green Pea - 00630414974040

Green Pea -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385690
In Commercial Distribution

  • 00630414974040 ()
F12L2

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

IMMULITE® 2000 Systems Microsampling Tubes - 00630414973937

Microsampling Tubes - IMMULITE - CONS - 1000 Pieces
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
10385207
In Commercial Distribution

  • 00630414973937 ()
LMST

  • General specimen container IVD, no additive/medium

IMMULITE®2000 Systems 3gAllergy™ Privet - 00630414973777

Privet-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386071
In Commercial Distribution

  • 00630414973777 ()
T210L2

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

IMMULITE®2000 Systems 3gAllergy™ Russian Thistle - 00630414973760

Russian Thistle -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386132
In Commercial Distribution

  • 00630414973760 ()
W11L2

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

IMMULITE®2000 Systems 3gAllergy™ Sheep Sorrel - 00630414973753

Sheep Sorrel -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386139
In Commercial Distribution

  • 00630414973753 ()
W18L2

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

IMMULITE® Systems LH Calibration Verification Material LH - 00630414973715

LH CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388034
In Commercial Distribution

  • 00630414973715 ()
LLHCVM

  • Luteinizing hormone (LH) IVD, control

IMMULITE® Systems FSH Calibration Verification Material FSH - 00630414973623

FSH CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387977
In Commercial Distribution

  • 00630414973623 ()
LFSCVM

  • Follicle stimulating hormone (FSH) IVD, control

IMMULITE®2000 Systems 3gAllergy™ White Ash - 00630414973548

White Ash -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386060
In Commercial Distribution

  • 00630414973548 ()
T15L2

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

IMMULITE®2000 Systems 3gAllergy™ Melon - 00630414973524

Melon -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385864
In Commercial Distribution

  • 00630414973524 ()
F87L2

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