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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IGF-I - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381448
In Commercial Distribution

  • 00630414961538 ()
L2KGF2

  • Insulin-like growth factor I (IGF1) IVD, kit, chemiluminescent immunoassay
Gastrin - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380979
In Commercial Distribution

  • 00630414961521 ()
L2KGA2

  • Gastrin IVD, kit, chemiluminescent immunoassay
FSH - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381180
In Commercial Distribution

  • 00630414961514 ()
L2KFS6

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
FSH - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381201
In Commercial Distribution

  • 00630414961507 ()
L2KFS2

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
Folic Acid - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380912
In Commercial Distribution

  • 00630414961491 ()
L2KFO6

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay
Folic Acid - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380911
In Commercial Distribution

  • 00630414961484 ()
L2KFO2

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay
Ferritin - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380906
In Commercial Distribution

  • 00630414961477 ()
L2KFE6

  • Ferritin IVD, kit, chemiluminescent immunoassay
Ferritin - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380908
In Commercial Distribution

  • 00630414961460 ()
L2KFE2

  • Ferritin IVD, kit, chemiluminescent immunoassay
Free T3 - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381682
In Commercial Distribution

  • 00630414961385 ()
L2KF36

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
Free T3 - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381675
In Commercial Distribution

  • 00630414961361 ()
L2KF32

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
DHEA-S - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381193
In Commercial Distribution

  • 00630414961309 ()
L2KDS2

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay
Digoxin - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381529
In Commercial Distribution

  • 00630414961286 ()
L2KDI2

  • Digoxin therapeutic drug monitoring IVD, kit, chemiluminescent assay
Digitoxin - Immulite 2000
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381538
In Commercial Distribution

  • 00630414961262 ()
L2KDG2

  • Multiple therapeutic drugs/drugs of abuse IVD, control
  • Digitoxin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
CMV IgG Ab - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381309
In Commercial Distribution

  • 00630414961231 ()
L2KCVG2

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
CRP Cardiophase - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381043
In Commercial Distribution

  • 00630414961200 ()
L2KCRP2

  • C-reactive protein (CRP) IVD, reagent
Cortisol - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381480
In Commercial Distribution

  • 00630414961194 ()
L2KCO6

  • Total cortisol IVD, kit, chemiluminescent immunoassay
Cortisol - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381476
In Commercial Distribution

  • 00630414961187 ()
L2KCO2

  • Total cortisol IVD, kit, chemiluminescent immunoassay
Calcitonin - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381446
In Commercial Distribution

  • 00630414961156 ()
L2KCL2

  • Calcitonin IVD, kit, chemiluminescent immunoassay
HCG Total - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381194
In Commercial Distribution

  • 00630414961149 ()
L2KCG6

  • Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay
HCG Total - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381206
In Commercial Distribution

  • 00630414961132 ()
L2KCG2

  • Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay
CEA - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380995
In Commercial Distribution

  • 00630414961125 ()
L2KCE6

  • Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
CEA - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380994
In Commercial Distribution

  • 00630414961118 ()
L2KCE2

  • Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
Carbamazepine - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381550
In Commercial Distribution

  • 00630414961095 ()
L2KCB2

  • Carbamazepine therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
CA 15-3 - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380983
In Commercial Distribution

  • 00630414961088 ()
L2KBR2

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
b2 Microglobulin - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380992
In Commercial Distribution

  • 00630414961071 ()
L2KBM2

  • Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay
AF AFP Kit 600 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381184
In Commercial Distribution

  • 00630414961040 ()
L2KAP6

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay
AF AFP Kit 200 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381187
In Commercial Distribution

  • 00630414961033 ()
L2KAP2

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay
Androstenedione - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381188
In Commercial Distribution

  • 00630414961026 ()
L2KAO2

  • Androstenedione IVD, kit, chemiluminescent immunoassay
ACTH - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381468
In Commercial Distribution

  • 00630414960999 ()
L2KAC2

  • Adrenocorticotropic hormone (ACTH) IVD, kit, chemiluminescent immunoassay
ID4 Sample Diluent
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381266
In Commercial Distribution

  • 00630414960975 ()
  • 00630414601748 ()
L1KMCW1

  • Buffered sample diluent IVD
Torch IGG/IGM - IMMULITE - CONS - 2 wedges
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387608
In Commercial Distribution

  • 00630414960951 ()
L1KIGW1

  • Buffered sample diluent IVD
Infectious Disease Diluent - IMMULITE - CAL
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385353
In Commercial Distribution

  • 00630414960944 ()
L1KIDW1

  • Buffered sample diluent IVD
HCG Diluent Module - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385351
In Commercial Distribution

  • 00630414960920 ()
L1KCGW1

  • Buffered sample diluent IVD
Latex-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385996
In Commercial Distribution

  • 00630414960876 ()
K82L4

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Cockroach-Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385959
In Commercial Distribution

  • 00630414960722 ()
I6L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Paper Wasp Venom -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385957
In Commercial Distribution

  • 00630414960715 ()
I4L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Yellow Jacket Venom -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385956
In Commercial Distribution

  • 00630414960708 ()
I3L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
White Faced Hornet -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385955
In Commercial Distribution

  • 00630414960692 ()
I2L2

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Honey Bee Venom -Specific IgE - IMMULITE - RGT
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385950
In Commercial Distribution

  • 00630414960685 ()
I1L4

  • Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent
Dust Panel 1 - IMMULITE - RGT - 40 test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10385948
In Commercial Distribution

  • 00630414960678 ()
HP1L4

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