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

  • 00630414973234 ()
F26L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
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
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
Blueberry-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385776
In Commercial Distribution

  • 00630414973203 ()
F288L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Oyster-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385778
In Commercial Distribution

  • 00630414973197 ()
F290L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Crab -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385739
In Commercial Distribution

  • 00630414973180 ()
F23L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
HCG Sample Diluent - IMMULITE - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386977
In Commercial Distribution

  • 00630414973173 ()
LCGZ

  • Buffered sample diluent IVD
Beta 2 Microglobulin Sample Diluent - IMMULITE - 1x100mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387017
In Commercial Distribution

  • 00630414973081 ()
LBMZ4

  • Buffered sample diluent IVD
HCG Sample Diluent - IMMULITE - 1x100mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386978
In Commercial Distribution

  • 00630414973067 ()
LCGZ4

  • Buffered sample diluent IVD
Beta 2 Microglobulin Sample Diluent - IMMULITE - 1x25mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387016
In Commercial Distribution

  • 00630414973005 ()
LBMZ

  • Buffered sample diluent IVD
T4 Total - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381685
In Commercial Distribution

  • 00630414972992 ()
L2KT42

  • Total thyroxine (TT4) IVD, kit, chemiluminescent immunoassay
Sunflower-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385998
In Commercial Distribution

  • 00630414972947 ()
K84L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
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
SHBG Diluent - IMMULITE - CAL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385366
In Commercial Distribution

  • 00630414972831 ()
L1KSHW1

  • Buffered sample diluent IVD
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
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
Yogurt-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385810
In Commercial Distribution

  • 00630414972602 ()
F360L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Lime-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385789
In Commercial Distribution

  • 00630414972527 ()
F306L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Oregano-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385773
In Commercial Distribution

  • 00630414972503 ()
F283L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Thyreoglobulin - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381647
In Commercial Distribution

  • 00630414972084 ()
L2KTY2(D)

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
Thyreoglobulin - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381638
In Commercial Distribution

  • 00630414972077 ()
LKTY1(D)

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
IMMULITE®/IMMULITE® 1000 Systems Rubella IgM
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10374044
Not in Commercial Distribution

  • 00630414971582 ()
LKRM1(D)

  • Rubella virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
fPS Free PSA Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10374043
In Commercial Distribution

  • 00630414971575 ()
LKPF1(D)

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
HBS HBsAg Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10374038
Not in Commercial Distribution

  • 00630414971551 ()
LKHB1(D)

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay
HBsAg Confirmatory Kit
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10374036
Not in Commercial Distribution

  • 00630414971544 ()
LKCH(D)

  • Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay
Toxoplasma IgM Ab - IMMULITE - RGT - 200 tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10374023
In Commercial Distribution

  • 00630414971483 ()
L2KTM2(D)

  • Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Sycamore -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386057
In Commercial Distribution

  • 00630414965154 ()
T11L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Walnut -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386056
In Commercial Distribution

  • 00630414965147 ()
T10L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
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
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
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
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
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
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
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
Substrate Module - IMMULITE - CONS - 2x500 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385394
In Commercial Distribution

  • 00630414965017 ()
LSUBX

  • Chemiluminescent immunoassay signal generation kit IVD
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
Myoglobin - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381020
Not in Commercial Distribution

  • 00630414964942 ()
LSKMY1

  • Myoglobin IVD, kit, chemiluminescent immunoassay
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
Vitamin B12 - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380900
In Commercial Distribution

  • 00630414964874 ()
LKVB1

  • Vitamin B12 IVD, kit, chemiluminescent immunoassay
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
Toxoplasma IgG Ab - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381268
In Commercial Distribution

  • 00630414964805 ()
LKTXP1

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Testosterone - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381156
In Commercial Distribution

  • 00630414964782 ()
LKTW1

  • Total testosterone IVD, kit, chemiluminescent immunoassay
TSH - IMMULITE - RGT - 500 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381627
In Commercial Distribution

  • 00630414964775 ()
LKTS5

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
TSH - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381620
In Commercial Distribution

  • 00630414964768 ()
LKTS1

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
TPO Ab - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381618
In Commercial Distribution

  • 00630414964744 ()
LKTO1

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, chemiluminescent immunoassay
TG Ab - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381641
In Commercial Distribution

  • 00630414964676 ()
LKTG1

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
TBG - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381643
In Commercial Distribution

  • 00630414964652 ()
LKTB1

  • Thyroxine binding globulin (TBG) IVD, kit, chemiluminescent immunoassay
Rubella IgG Ab - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381292
In Commercial Distribution

  • 00630414964614 ()
LKRUB1

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
TSH - IMMULITE - RGT - 500 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381628
In Commercial Distribution

  • 00630414964607 ()
LKRT5

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