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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™ 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 SUBS - 00630414965017

Substrate Module - IMMULITE - CONS - 2x500 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385394
In Commercial Distribution

  • 00630414965017 ()
LSUBX

  • Chemiluminescent immunoassay signal generation kit IVD

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 RMY Turbo Myoglobin - 00630414964942

Myoglobin - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381020
Not in Commercial Distribution

  • 00630414964942 ()
LSKMY1

  • Myoglobin IVD, kit, chemiluminescent immunoassay

IMMULITE®/IMMULITE® 1000 Systems RHC Turbo HCG - 00630414964898

HCG Total - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381169
Not in Commercial Distribution

  • 00630414964898 ()
LSKCG1

  • Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay

IMMULITE®/IMMULITE® 1000 Systems VB Vitamin B12 - 00630414964874

Vitamin B12 - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380900
In Commercial Distribution

  • 00630414964874 ()
LKVB1

  • Vitamin B12 IVD, kit, chemiluminescent immunoassay

IMMULITE®/IMMULITE® 1000 Systems VAL Valproic Acid - 00630414964850

Valproic Acid - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381509
In Commercial Distribution

  • 00630414964850 ()
LKVA1

  • Valproic acid therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
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