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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™ Rabbit Bush - 00630414979175

Rabbit Bush-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386152
In Commercial Distribution

  • 00630414979175 ()
W36L2

  • 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

IMMULITE®2000 Systems 3gAllergy™ Queen Palm - 00630414979076

Queen Palm -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386103
In Commercial Distribution

  • 00630414979076 ()
T72L2

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

IMMULITE®2000 Systems 3gAllergy™ Red Mulberry - 00630414979069

Red Mulberry-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386102
In Commercial Distribution

  • 00630414979069 ()
T71L2

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

IMMULITE®2000 Systems 3gAllergy™ Loblolly Pine - 00630414979038

Loblolly Pine-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386094
In Commercial Distribution

  • 00630414979038 ()
T43L2

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

IMMULITE®2000 Systems 3gAllergy™ White Hickory - 00630414979021

White Hickory-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386092
In Commercial Distribution

  • 00630414979021 ()
T41L2

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

IMMULITE®2000 Systems 3gAllergy™ Brazilian Peppertree - 00630414978994

Brazilian Peppertree-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386088
In Commercial Distribution

  • 00630414978994 ()
T401L2

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

IMMULITE®2000 Systems 3gAllergy™ White Bald Cypress - 00630414978987

White Bald Cypress-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386085
In Commercial Distribution

  • 00630414978987 ()
T37L2

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

IMMULITE®2000 Systems 3gAllergy™ Locust Tree - 00630414978963

Locust Tree-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386081
In Commercial Distribution

  • 00630414978963 ()
T280L2

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

IMMULITE®2000 Systems 3gAllergy™ Red Maple - 00630414978956

Red Maple-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386080
In Commercial Distribution

  • 00630414978956 ()
T27L2

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

IMMULITE®2000 Systems 3gAllergy™ Pecan - 00630414978949

Pecan -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386077
In Commercial Distribution

  • 00630414978949 ()
T22L2

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

IMMULITE®2000 Systems 3gAllergy™ Bayberry/Sweet Gale - 00630414978932

Bayberry/Sweet Gale-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386073
In Commercial Distribution

  • 00630414978932 ()
T218L2

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

IMMULITE®2000 Systems 3gAllergy™ Sweet Gum - 00630414978925

Sweet Gum-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386072
In Commercial Distribution

  • 00630414978925 ()
T211L2

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

IMMULITE®2000 Systems 3gAllergy™ Live Oak Tree - 00630414978901

Live Oak -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386055
In Commercial Distribution

  • 00630414978901 ()
T103L2

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

IMMULITE®2000 Systems 3gAllergy™ Tabacco - 00630414978895

Tobacco-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386050
In Commercial Distribution

  • 00630414978895 ()
O201L2

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

IMMULITE®2000 Systems 3gAllergy™ Hormodendrum hordei - 00630414978888

Hormodendrum hordei-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386037
In Commercial Distribution

  • 00630414978888 ()
M45L2

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

IMMULITE®2000 Systems 3gAllergy™ Penicillium brevi-compactum - 00630414978833

Penicillium brevi-compactum-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386030
In Commercial Distribution

  • 00630414978833 ()
M305L2

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

IMMULITE®2000 Systems 3gAllergy™ Aureobasidium pullulans - 00630414978789

Aureobasidium pullulans -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386013
In Commercial Distribution

  • 00630414978789 ()
M12L2

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

IMMULITE®2000 Systems 3gAllergy™ Canary Grass - 00630414978710

Canary Grass-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385926
In Commercial Distribution

  • 00630414978710 ()
G71L2

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

IMMULITE®2000 Systems 3gAllergy™ Meadow Foxtail Grass - 00630414978697

Meadow Foxtail Grass -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385911
In Commercial Distribution

  • 00630414978697 ()
G16L2

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

IMMULITE®2000 Systems 3gAllergy™ Perch - 00630414978666

Perch-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385843
In Commercial Distribution

  • 00630414978666 ()
F65L2

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

IMMULITE®2000 Systems 3gAllergy™ Sweet Potato - 00630414978628

Sweet Potato-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385836
In Commercial Distribution

  • 00630414978628 ()
F54L2

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

IMMULITE®2000 Systems 3gAllergy™ Chub Makerel - 00630414978611

Chub Mackerel-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385835
In Commercial Distribution

  • 00630414978611 ()
F50L2

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

IMMULITE®2000 Systems 3gAllergy™ Haddock - 00630414978604

Haddock-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385826
In Commercial Distribution

  • 00630414978604 ()
F42L2

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

IMMULITE®2000 Systems 3gAllergy™ Asparagus - 00630414978543

Asparagus-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385755
In Commercial Distribution

  • 00630414978543 ()
F261L2

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

IMMULITE®2000 Systems 3gAllergy™ Sugar Cane - 00630414978529

Sugar Cane-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385724
In Commercial Distribution

  • 00630414978529 ()
F21L2

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

IMMULITE®2000 Systems 3gAllergy™ Lima Bean - 00630414978468

Lima Bean-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385700
In Commercial Distribution

  • 00630414978468 ()
F182L2

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

IMMULITE®2000 Systems 3gAllergy™ Flounder - 00630414978444

Flounder-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385693
In Commercial Distribution

  • 00630414978444 ()
F147L2

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

IMMULITE®/IMMULITE® 1000 Systems TU Thyroid Uptake - 00630414978222

T Uptake - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381619
In Commercial Distribution

  • 00630414978222 ()
LKTU1

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

IMMULITE® Systems SBG Calibration Verification Material SHBG - 00630414978048

SHBG CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373703
In Commercial Distribution

  • 00630414978048 ()
LSHCVM

  • Sex hormone binding globulin (SHBG) IVD, control

IMMULITE Systems Androstenedione Calibration Verification Material - 00630414978031

Androstenedione CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373680
In Commercial Distribution

  • 00630414978031 ()
LAOCVM

  • Androstenedione IVD, control

Dimension® ANEM CAL - 00630414976631

LOCI Anemia Calibrator, 2 X 5 X 1.0 mL
Siemens Healthcare Diagnostics Inc.
10463372
In Commercial Distribution

  • 00630414976631 ()
RC640

  • Multiple anaemia-related analyte IVD, calibrator

Diff-Quik™ Solution II - 00630414976327

For differential staining in hematology that gives results similar to a Wright-Giemsa stain
Siemens Healthcare Diagnostics Products GmbH
10459381
Not in Commercial Distribution

  • 00630414976327 ()
B4132-12A

  • Differentiation solution IVD

Diff-Quik™ Solution I - 00630414976310

For differential staining in hematology that gives results similar to a Wright-Giemsa stain
Siemens Healthcare Diagnostics Products GmbH
10459380
Not in Commercial Distribution

  • 00630414976310 ()
B4132-11A

  • Differentiation solution IVD

IMMULITE®2000 Systems 3gAllergy™ Blomia tropicalis - 00630414975511

Blomia tropicalis-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385631
In Commercial Distribution

  • 00630414975511 ()
D201L2

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

IMMULITE®2000 Systems 3gAllergy™ Brazil Nut - 00630414975498

Brazil Nut -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385701
In Commercial Distribution

  • 00630414975498 ()
F18L2

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