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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Insulin-like growth factor I (IGF-I) 100 test kit
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
11128584
Not in Commercial Distribution

  • 00630414601243 ()
LKIGF1

  • Insulin-like growth factor I (IGF1) IVD, kit, chemiluminescent immunoassay
IMMULITE(R) 2000 TSI Assay
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10876421
In Commercial Distribution

  • 00630414597188 ()
L2KSI2(D)

  • Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, chemiluminescent immunoassay
The Hematek slide stainer is a fully automated, bench-top hematology system for in vitro diagnostic use in the clinical laboratoy
Siemens Healthcare Diagnostics Products GmbH
10805311
In Commercial Distribution

  • 00630414596563 ()
10805311

  • Microscope slide stainer IVD
Phenobarbital - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381512
Not in Commercial Distribution

  • 00630414964379 ()
LKPB1

  • Phenobarbital therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
PAP - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380953
Not in Commercial Distribution

  • 00630414964355 ()
LKPA1

  • Prostatic acid phosphatase (PAP) IVD, kit, chemiluminescent immunoassay
CA 125 - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380969
Not in Commercial Distribution

  • 00630414964331 ()
LKOP1

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
Myoglobin - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381023
Not in Commercial Distribution

  • 00630414964270 ()
LKMY1

  • Myoglobin IVD, kit, chemiluminescent immunoassay
LH - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381141
Not in Commercial Distribution

  • 00630414964225 ()
LKLH1

  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay
HSV I and II IgG Ab - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381274
Not in Commercial Distribution

  • 00630414964171 ()
LKHS1

  • Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Helicobacter pylori IgG Ab - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381272
Not in Commercial Distribution

  • 00630414964164 ()
LKHPG1

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Homocystein - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381029
Not in Commercial Distribution

  • 00630414964157 ()
LKHO1

  • Homocysteine IVD, kit, chemiluminescent immunoassay
Albumin - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381385
Not in Commercial Distribution

  • 00630414964096 ()
LKHA1

  • Albumin IVD, kit, enzyme immunoassay (EIA)
hGH - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381433
Not in Commercial Distribution

  • 00630414964089 ()
LKGRH1

  • Human growth hormone (HGH) IVD, kit, chemiluminescent immunoassay
IGF-I - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381403
In Commercial Distribution

  • 00630414964041 ()
LKGF1

  • Insulin-like growth factor I (IGF1) IVD, kit, chemiluminescent immunoassay
Gastrin - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380962
Not in Commercial Distribution

  • 00630414964034 ()
LKGA1

  • Gastrin IVD, kit, chemiluminescent immunoassay
FSH - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381153
Not in Commercial Distribution

  • 00630414964010 ()
LKFS1

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay
Ferritin - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380898
Not in Commercial Distribution

  • 00630414963976 ()
LKFE1

  • Ferritin IVD, kit, chemiluminescent immunoassay
Free T3 - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381626
Not in Commercial Distribution

  • 00630414963938 ()
LKF31

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay
DHEA-S - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381130
Not in Commercial Distribution

  • 00630414963884 ()
LKDS1

  • Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, chemiluminescent immunoassay
Digoxin - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381517
Not in Commercial Distribution

  • 00630414963860 ()
LKDI1

  • Digoxin therapeutic drug monitoring IVD, kit, chemiluminescent assay
Digitoxin - Immulite/Immulite 1000
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381508
Not in Commercial Distribution

  • 00630414963846 ()
LKDG1

  • Multiple therapeutic drugs/drugs of abuse IVD, control
  • Digitoxin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
CMV IgG Ab - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381289
Not in Commercial Distribution

  • 00630414963822 ()
LKCV1

  • Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
CRP Cardiophase - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10286287
Not in Commercial Distribution

  • 00630414963792 ()
LKCRP1

  • C-reactive protein (CRP) IVD, reagent
Cortisol - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381388
Not in Commercial Distribution

  • 00630414963761 ()
LKCO1

  • Total cortisol IVD, kit, chemiluminescent immunoassay
Calcitonin - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381401
Not in Commercial Distribution

  • 00630414963730 ()
LKCL1

  • Calcitonin IVD, kit, chemiluminescent immunoassay
HCG Total - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381161
Not in Commercial Distribution

  • 00630414963716 ()
LKCG1

  • Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay
CEA - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380945
Not in Commercial Distribution

  • 00630414963693 ()
LKCE1

  • Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
Carbamazepine - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381505
Not in Commercial Distribution

  • 00630414963679 ()
LKCB1

  • Carbamazepine therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
CA 15-3 - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380948
Not in Commercial Distribution

  • 00630414963655 ()
LKBR1

  • Cancer antigen 15-3 (CA15-3) IVD, kit, chemiluminescent immunoassay
b2 Microglobulin - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380950
Not in Commercial Distribution

  • 00630414963648 ()
LKBM1

  • Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay
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