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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™ 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®/IMMULITE® 1000 Systems RPT Turbo Intact PTH - 00630414964980

PTH intact - IMMULITE - RGT - 50 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381430
Not in Commercial Distribution

  • 00630414964980 ()
LSKPTZ

  • Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay

IMMULITE®/IMMULITE® 1000 Systems TES Total Testosterone - 00630414964782

Testosterone - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381156
In Commercial Distribution

  • 00630414964782 ()
LKTW1

  • Total testosterone IVD, kit, chemiluminescent immunoassay

IMMULITE®/IMMULITE® 1000 Systems TSH Third Generation TSH - 00630414964775

TSH - IMMULITE - RGT - 500 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381627
In Commercial Distribution

  • 00630414964775 ()
LKTS5

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

IMMULITE®/IMMULITE® 1000 Systems TSH Third Generation TSH - 00630414964768

TSH - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381620
In Commercial Distribution

  • 00630414964768 ()
LKTS1

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

IMMULITE®/IMMULITE® 1000 Systems RTH Rapid TSH - 00630414964607

TSH - IMMULITE - RGT - 500 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381628
In Commercial Distribution

  • 00630414964607 ()
LKRT5

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

IMMULITE®/IMMULITE® 1000 Systems RTH Rapid TSH - 00630414964591

TSH - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381637
In Commercial Distribution

  • 00630414964591 ()
LKRT1

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

IMMULITE®/IMMULITE® 1000 Systems PRL Prolactin - 00630414964539

Prolactin - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381145
In Commercial Distribution

  • 00630414964539 ()
LKPR1

  • Prolactin IVD, kit, chemiluminescent immunoassay

IMMULITE®/IMMULITE® 1000 Systems iPT Intact PTH - 00630414964515

PTH intact - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381399
In Commercial Distribution

  • 00630414964515 ()
LKPP1

  • Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay

IMMULITE®/IMMULITE® 1000 Systems DPD Pyrlinks-D - 00630414964416

Pyrilinks-D - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381389
In Commercial Distribution

  • 00630414964416 ()
LKPD1

  • Collagen pyridium crosslink IVD, kit, chemiluminescent immunoassay

IMMULITE®/IMMULITE® 1000 Systems LH - 00630414964225

LH - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381141
In Commercial Distribution

  • 00630414964225 ()
LKLH1

  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay

IMMULITE/IMMULITE 1000 Systems Growth Hormone (Recombinant 98/574) - 00630414964089

hGH - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381433
In Commercial Distribution

  • 00630414964089 ()
LKGRH1

  • Human growth hormone (HGH) IVD, kit, chemiluminescent immunoassay

IMMULITE®/IMMULITE® 1000 Systems IG1 IGF-1 - 00630414964041

IGF-I - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381403
In Commercial Distribution

  • 00630414964041 ()
LKGF1

  • Insulin-like growth factor I (IGF1) IVD, kit, chemiluminescent immunoassay

IMMULITE®/IMMULITE® 1000 Systems FSH - 00630414964010

FSH - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381153
In Commercial Distribution

  • 00630414964010 ()
LKFS1

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay

IMMULITE®/IMMULITE® 1000 Systems DHS DHEA-SO4 - 00630414963884

DHEA-S - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381130
In Commercial Distribution

  • 00630414963884 ()
LKDS1

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay

IMMULITE®/IMMULITE® 1000 Systems AND Androstenedione - 00630414963570

Androstenedione - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381158
In Commercial Distribution

  • 00630414963570 ()
LKAO1

  • Androstenedione IVD, kit, chemiluminescent immunoassay

IMMULITE®/IMMULITE® 1000 Systems ACT ACTH - 00630414963532

ACTH - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381415
In Commercial Distribution

  • 00630414963532 ()
LKAC1

  • Adrenocorticotropic hormone (ACTH) IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems TES Total Testosterone - 00630414962221

Testosterone - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381191
In Commercial Distribution

  • 00630414962221 ()
L2KTW6

  • Total testosterone IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems TES Total Testosterone - 00630414962214

Testosterone - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381190
In Commercial Distribution

  • 00630414962214 ()
L2KTW2

  • Total testosterone IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems TU Thyroid Uptake - 00630414962207

T Uptake - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381669
In Commercial Distribution

  • 00630414962207 ()
L2KTU2

  • Multiple thyroid hormone uptake (T-uptake) IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems TSH Third Generation TSH - 00630414962184

TSH - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381667
In Commercial Distribution

  • 00630414962184 ()
L2KTS6

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems TSH Third Generation TSH - 00630414962160

TSH - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381665
In Commercial Distribution

  • 00630414962160 ()
L2KTS2

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems RTH Rapid TSH - 00630414962030

TSH - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381652
In Commercial Distribution

  • 00630414962030 ()
L2KRT6

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems RTH Rapid TSH - 00630414962016

TSH - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381651
In Commercial Distribution

  • 00630414962016 ()
L2KRT2

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems PRG Progesterone - 00630414961989

Progesterone - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381170
In Commercial Distribution

  • 00630414961989 ()
L2KPW6

  • Progesterone IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems PRG Progesterone - 00630414961972

Progesterone - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381181
In Commercial Distribution

  • 00630414961972 ()
L2KPW2

  • Progesterone IVD, kit, chemiluminescent immunoassay
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