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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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IMMULITE®/IMMULITE® 1000 Systems RHC Turbo HCG - 00630414964898

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

IMMULITE®/IMMULITE® 1000 Systems VB Vitamin B12 - 00630414964874

Vitamin B12 - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10380900
In Commercial Distribution

  • 00630414964874 ()
LKVB1

  • Vitamin B12 IVD, kit, chemiluminescent immunoassay

IMMULITE®/IMMULITE® 1000 Systems VAL Valproic Acid - 00630414964850

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

IMMULITE®/IMMULITE® 1000 Systems TXP Toxoplasma Quantitative IgG - 00630414964805

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

IMMULITE®/IMMULITE® 1000 Systems TES Total Testosterone - 00630414964782

Testosterone - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381156
In Commercial Distribution

  • 00630414964782 ()
LKTW1

  • Total testosterone IVD, kit, chemiluminescent immunoassay

IMMULITE®/IMMULITE® 1000 Systems TSH Third Generation TSH - 00630414964775

TSH - IMMULITE - RGT - 500 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381627
In Commercial Distribution

  • 00630414964775 ()
LKTS5

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

IMMULITE®/IMMULITE® 1000 Systems TSH Third Generation TSH - 00630414964768

TSH - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381620
In Commercial Distribution

  • 00630414964768 ()
LKTS1

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

IMMULITE®/IMMULITE® 1000 Systems ATA Anti -TPO Ab - 00630414964744

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

IMMULITE/IMMULITE 1000 Systems ATG Anti-TG Ab - 00630414964676

TG Ab - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381641
In Commercial Distribution

  • 00630414964676 ()
LKTG1

  • Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay

IMMULITE®/IMMULITE® 1000 Systems TBG - 00630414964652

TBG - IMMULITE - RGT - 100 Tests
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10381643
In Commercial Distribution

  • 00630414964652 ()
LKTB1

  • Thyroxine binding globulin (TBG) IVD, kit, chemiluminescent immunoassay
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