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

  • 00630414978604 ()
F42L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Asparagus-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385755
In Commercial Distribution

  • 00630414978543 ()
F261L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
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
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
Flounder-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385693
In Commercial Distribution

  • 00630414978444 ()
F147L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Thyreoglobulin - IMMULITE - CONS - 3x2mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385247
In Commercial Distribution

  • 00630414978345 ()
LTYCM(D)

  • Thyroglobulin IVD, control
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
SHBG CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373703
In Commercial Distribution

  • 00630414978048 ()
LSHCVM

  • Sex hormone binding globulin (SHBG) IVD, control
Androstenedione CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373680
In Commercial Distribution

  • 00630414978031 ()
LAOCVM

  • Androstenedione IVD, control
Anti-HBc IgM CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10373676
In Commercial Distribution

  • 00630414978017 ()
L2MCCVM

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control
BcM Anti-HBc IgM Kit 200 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10488616
In Commercial Distribution

  • 00630414977737 ()
L2KMC2(D)

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
BcM Anti-HBc IgM Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10488615
Not in Commercial Distribution

  • 00630414977720 ()
LKMC1(D)

  • Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
Cortisol Sample Diluent CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10487396
In Commercial Distribution

  • 00630414977485 ()
LCOCVM

  • Total cortisol IVD, control
fPS Free PSA Kit 200 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10487239
In Commercial Distribution

  • 00630414977478 ()
L2KPF2(D)

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
Syphilis - IMMULITE - RGT - 200 tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10471981
In Commercial Distribution

  • 00630414976891 ()
L2KSY2(D)

  • Treponema pallidum total antibody IVD, kit, chemiluminescent immunoassay
Toxoplasma IGG - IMMULITE - CTL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10469600
In Commercial Distribution

  • 00630414976747 ()
LTXPCM

  • Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control
Rubella IGG - IMMULITE - CTL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10469599
In Commercial Distribution

  • 00630414976730 ()
LRUBCM

  • Rubella virus immunoglobulin G (IgG) antibody IVD, control
Rubella IGM - IMMULITE - CTL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10469597
In Commercial Distribution

  • 00630414976716 ()
LRMCM

  • Rubella virus immunoglobulin M (IgM) antibody IVD, control
CMV IgG - IMMULITE - CTL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10469595
In Commercial Distribution

  • 00630414976709 ()
LCVGCM

  • Cytomegalovirus (CMV) antigen IVD, control
Syphillis - IMMULITE - CTL - 2x6mL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10469593
In Commercial Distribution

  • 00630414976686 ()
LSYCM

  • Treponema pallidum reagin antibody IVD, control
Qualitative Solubility for sickling hemoglobin
Siemens Healthcare Diagnostics Products GmbH
10459402
In Commercial Distribution

  • 00630414976365 ()
B4585-5

  • Haemoglobin S (HbS) IVD, reagent
For testing for the presence of hemoglobin S in solubility tests and hemoglobing electrophoresis
Siemens Healthcare Diagnostics Products GmbH
10459401
In Commercial Distribution

  • 00630414976358 ()
B4585-10

  • Haemoglobin S (HbS) IVD, control
Qualitative Solubility for sickling hemoglobin
Siemens Healthcare Diagnostics Products GmbH
10459400
In Commercial Distribution

  • 00630414976341 ()
B4585-1

  • Haemoglobin S (HbS) IVD, reagent
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
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
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
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
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
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
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
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