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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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ADVIA Centaur® iPTH Calibrator - 00630414587486

PTH intact - CENTAUR - CAL 56 - 6 pack (REF)
Siemens Healthcare Diagnostics Inc.
10630628
In Commercial Distribution

  • 00630414587486 ()
10630628

  • Parathyroid hormone (PTH) IVD, calibrator

ADVIA Centaur® iPTH QC Ref - 00630414587479

PTH intact - CENTAUR - CTL - 2 pack (REF)
Siemens Healthcare Diagnostics Inc.
10630627
In Commercial Distribution

  • 00630414587479 ()
10630627

  • Parathyroid hormone (PTH) IVD, control

IMMULITE® Systems COR Calibration Verification Material Cortisol - 00630414977485

Cortisol Sample Diluent CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10487396
In Commercial Distribution

  • 00630414977485 ()
LCOCVM

  • Total cortisol IVD, control

IMMULITE® Systems T4 Calibration Verification Material Total T4 - 00630414973807

TOTAL T4 CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388142
In Commercial Distribution

  • 00630414973807 ()
LT4CVM

  • Total thyroxine (TT4) IVD, control

IMMULITE Systems Rubella Quantitative IgG CVM - 00630414973784

Rubella Quantitative IgG CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388114
In Commercial Distribution

  • 00630414973784 ()
LRUBCVM

  • Rubella virus immunoglobulin G (IgG) antibody IVD, control

IMMULITE® Systems INS Calibration Verification Material Insulin - 00630414973708

Insulin CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388005
In Commercial Distribution

  • 00630414973708 ()
LINCVM

  • Insulin IVD, control

IMMULITE® Systems TIE Calibration Verification Material Total IgE - 00630414973692

IgE Total CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10388001
In Commercial Distribution

  • 00630414973692 ()
LIECVM

  • Total immunoglobulin E (IgE total) IVD, control

IMMULITE® Systems HPG Calibration Verification Material H. pylori IgG - 00630414973678

H. Pylori CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387993
In Commercial Distribution

  • 00630414973678 ()
LHPGCVM

  • Helicobacter pylori immunoglobulin G (IgG) antibody IVD, control

IMMULITE® Systems HCY Calibration Verification Material Homocysteine - 00630414973661

Homocysteine CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387991
In Commercial Distribution

  • 00630414973661 ()
LHOCVM

  • Homocysteine IVD, control

IMMULITE® Systems IG1 Calibration Verification Material IGF-1 - 00630414973647

IGF-I CVM - IMMULITE - CONS
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10387979
In Commercial Distribution

  • 00630414973647 ()
LGFCVM

  • Insulin-like growth factor I (IGF1) IVD, control
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