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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CMV IgG Ab - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381289
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
In Commercial Distribution

  • 00630414963792 ()
LKCRP1

  • C-reactive protein (CRP) IVD, reagent
Cortisol - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381388
In Commercial Distribution

  • 00630414963761 ()
LKCO1

  • Total cortisol IVD, kit, chemiluminescent immunoassay
Calcitonin - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381401
In Commercial Distribution

  • 00630414963730 ()
LKCL1

  • Calcitonin IVD, kit, chemiluminescent immunoassay
HCG Total - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381161
In Commercial Distribution

  • 00630414963716 ()
LKCG1

  • Total human chorionic gonadotropin IVD, kit, chemiluminescent immunoassay
CEA - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380945
In Commercial Distribution

  • 00630414963693 ()
LKCE1

  • Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
Carbamazepine - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381505
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
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
In Commercial Distribution

  • 00630414963648 ()
LKBM1

  • Beta-2-microglobulin IVD, kit, chemiluminescent immunoassay
AF AFP Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381162
In Commercial Distribution

  • 00630414963594 ()
LKAP1

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay
Androstenedione - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381158
In Commercial Distribution

  • 00630414963570 ()
LKAO1

  • Androstenedione IVD, kit, chemiluminescent immunoassay
ACTH - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381415
In Commercial Distribution

  • 00630414963532 ()
LKAC1

  • Adrenocorticotropic hormone (ACTH) IVD, kit, chemiluminescent immunoassay
Vitamin B12 - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380913
In Commercial Distribution

  • 00630414962320 ()
L2KVB6

  • Vitamin B12 IVD, kit, chemiluminescent immunoassay
Testosterone - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381190
In Commercial Distribution

  • 00630414962214 ()
L2KTW2

  • Total testosterone IVD, kit, chemiluminescent immunoassay
TSH - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381667
In Commercial Distribution

  • 00630414962184 ()
L2KTS6

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
TPO Ab - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381649
In Commercial Distribution

  • 00630414962153 ()
L2KTO6

  • Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, chemiluminescent immunoassay
TG Ab - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381655
In Commercial Distribution

  • 00630414962115 ()
L2KTG6

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
TBG - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381660
In Commercial Distribution

  • 00630414962078 ()
L2KTB2

  • Thyroxine binding globulin (TBG) IVD, kit, chemiluminescent immunoassay
Rubella IgG Ab - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381338
In Commercial Distribution

  • 00630414962054 ()
L2KRUB2

  • Rubella virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
TSH - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381651
In Commercial Distribution

  • 00630414962016 ()
L2KRT2

  • Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassay
Progesterone - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381170
In Commercial Distribution

  • 00630414961989 ()
L2KPW6

  • Progesterone IVD, kit, chemiluminescent immunoassay
Progesterone - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381181
In Commercial Distribution

  • 00630414961972 ()
L2KPW2

  • Progesterone IVD, kit, chemiluminescent immunoassay
Prolactin - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381199
In Commercial Distribution

  • 00630414961941 ()
L2KPR6

  • Prolactin IVD, kit, chemiluminescent immunoassay
Prolactin - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381200
In Commercial Distribution

  • 00630414961934 ()
L2KPR2

  • Prolactin IVD, kit, chemiluminescent immunoassay
PTH intact - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381442
In Commercial Distribution

  • 00630414961927 ()
L2KPP6

  • Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay
PTH intact - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381441
In Commercial Distribution

  • 00630414961910 ()
L2KPP2

  • Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassay
Phenytoin - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381548
In Commercial Distribution

  • 00630414961903 ()
L2KPN2

  • Phenytoin therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
C-Peptide - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381450
In Commercial Distribution

  • 00630414961873 ()
L2KPEP2

  • C-peptide IVD, kit, chemiluminescent immunoassay
Pyrilinks-D - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381461
In Commercial Distribution

  • 00630414961859 ()
L2KPD2

  • Collagen pyridium crosslink IVD, kit, chemiluminescent immunoassay
Phenobarbital - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381542
In Commercial Distribution

  • 00630414961828 ()
L2KPB2

  • Phenobarbital therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
PAP - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380975
In Commercial Distribution

  • 00630414961804 ()
L2KPA2

  • Prostatic acid phosphatase (PAP) IVD, kit, chemiluminescent immunoassay
CA 125 - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380972
In Commercial Distribution

  • 00630414961798 ()
L2KOP2

  • Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay
Myoglobin - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381031
In Commercial Distribution

  • 00630414961736 ()
L2KMY2

  • Myoglobin IVD, kit, chemiluminescent immunoassay
LH - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381212
In Commercial Distribution

  • 00630414961705 ()
L2KLH6

  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay
LH - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381211
In Commercial Distribution

  • 00630414961699 ()
L2KLH2

  • Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassay
Helicobacter pylori IgG Ab - IMMULITE - RGT - 600 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381335
In Commercial Distribution

  • 00630414961644 ()
L2KHPG6

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Helicobacter pylori IgG Ab - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381336
In Commercial Distribution

  • 00630414961637 ()
L2KHPG2

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Homocystein - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381040
In Commercial Distribution

  • 00630414961620 ()
L2KHO2

  • Homocysteine IVD, kit, chemiluminescent immunoassay
Albumin - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381453
In Commercial Distribution

  • 00630414961569 ()
L2KHA2

  • Albumin IVD, kit, enzyme immunoassay (EIA)
hGH - IMMULITE - RGT - 200 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381451
In Commercial Distribution

  • 00630414961552 ()
L2KGRH2

  • Human growth hormone (HGH) IVD, kit, chemiluminescent immunoassay
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