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® Zika IgM Controls
Siemens Healthcare Diagnostics Inc.
11200111
Not in Commercial Distribution

  • 00630414170886 ()
11200111

  • Zika virus immunoglobulin M (IgM) antibody IVD, control
ADVIA Centaur® Zika IgM Assay
Siemens Healthcare Diagnostics Inc.
11200103
Not in Commercial Distribution

  • 00630414170862 ()
11200103

  • Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
The Xprecia™ System PT Controls; For use with Xprecia System, supplying assayed controls for prothrombin time (PT).
Siemens Healthcare Diagnostics Inc.
10873633
In Commercial Distribution

  • 00630414170794 ()
10873633

  • Prothrombin time (PT) IVD, control
ADVIA Chemistry Systems 70-mL Wedges –Yellow
Siemens Healthcare Diagnostics Inc.
11223140
In Commercial Distribution

  • 00630414168258 ()
11223140

  • Assay container IVD, single-use
Anti-HBe2 (aHBe2) – ADVIA Centaur – QC Kit
Siemens Healthcare Diagnostics Inc.
10720832
In Commercial Distribution

  • 00630414167947 ()
10720832

  • Hepatitis B virus e-antigen total antibody IVD, control
Anti-HBe2 (aHBe2) – ADVIA Centaur – RGT 50T
Siemens Healthcare Diagnostics Inc.
10720831
In Commercial Distribution

  • 00630414167923 ()
10720831

  • Hepatitis B virus e-antigen total antibody IVD, kit, chemiluminescent immunoassay
Blank sensor to replace the K+/Ca++/Cl-sensor. An in vitro medical device used on Siemens Healthcare Diagnostics RAPIDLab® Series systems.
Siemens Healthcare Diagnostics Inc.
10311665
In Commercial Distribution

  • 00630414132075 ()
673702

  • Blood gas/haemoximetry analyser IVD, point-of-care
Blank Sensor used For GLU or LAC on Siemens Healthcare Diagnostics RAPIDLab® Series systems.
Siemens Healthcare Diagnostics Inc.
10326708
In Commercial Distribution

  • 00630414132051 ()
673701000

  • Lactate electrode IVD
Reference Test/Blank sensor, an in vitro diagnostics device to replace the Reference sensor on the RAPIDLab® 248/348/348ex analyzers
Siemens Healthcare Diagnostics Inc.
10327492
In Commercial Distribution

  • 00630414132013 ()
673396000

  • Blood gas/haemoximetry analyser IVD, point-of-care
RAPIDLyte Multicap blood collection capillary tubes (50 tubes) approx. volume 100µL. For capillary blood collection for the analysis of pH/Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb.
Siemens Healthcare Diagnostics Inc.
10323539
In Commercial Distribution

  • 00630414131986 ()
  • 00630414009520 ()
673394

  • Capillary blood collection tube IVD, electrolyte-balanced heparin
Prolactin Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311626
In Commercial Distribution

  • 00630414126326 ()
672430000

  • Prolactin IVD, control
Alpha-Fetoprotein (AFP) Master Curve Material Kit
Siemens Healthcare Diagnostics Inc.
10311625
In Commercial Distribution

  • 00630414126319 ()
672428000

  • Alpha-fetoprotein (AFP) IVD, control
CEA Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311624
In Commercial Distribution

  • 00630414126302 ()
672427000

  • Carcinoembryonic antigen (CEA) IVD, control
Digoxin Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311623
In Commercial Distribution

  • 00630414126296 ()
672426000

  • Digoxin therapeutic drug monitoring IVD, control
Free T3 Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311622
In Commercial Distribution

  • 00630414126289 ()
672425000

  • Free triiodothyronine (FT3) IVD, control
IgE Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311621
In Commercial Distribution

  • 00630414126265 ()
672423000

  • Total immunoglobulin E (IgE total) IVD, control
TSH Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311620
In Commercial Distribution

  • 00630414126258 ()
672422000

  • Thyroid stimulating hormone (TSH) IVD, control
T4 Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311619
In Commercial Distribution

  • 00630414126234 ()
672420000

  • Total thyroxine (TT4) IVD, control
Follicular Stimulating Hormone Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311617
In Commercial Distribution

  • 00630414126210 ()
672418000

  • Follicle stimulating hormone (FSH) IVD, control
Ferritin Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311616
In Commercial Distribution

  • 00630414126197 ()
672416000

  • Ferritin IVD, control
Vancomycin Master Curve Material Set - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311613
Not in Commercial Distribution

  • 00630414126111 ()
672362000

  • Vancomycin therapeutic drug monitoring IVD, control
T3 Diluent - CENTAUR - CAL - 1x10mL
Siemens Healthcare Diagnostics Inc.
10311588
In Commercial Distribution

  • 00630414125176 ()
672207000

  • Buffered sample diluent IVD
T4 Diluent - CENTAUR - CAL - 1x10mL
Siemens Healthcare Diagnostics Inc.
10311585
In Commercial Distribution

  • 00630414125121 ()
672202000

  • Buffered sample diluent IVD
Calibrator D - 6 pack (AFP Cal; CEA Cal)
Siemens Healthcare Diagnostics Inc.
10331182
In Commercial Distribution

  • 00630414124940 ()
672183005

  • Multiple tissue-associated protein/tumour marker IVD, calibrator
Calibrator D - 6 pack (AFP Cal; CEA Cal)
Siemens Healthcare Diagnostics Inc.
10311576
In Commercial Distribution

  • 00630414124933 ()
672183000

  • Multiple tissue-associated protein/tumour marker IVD, calibrator
Ferritin/VitB12 (Ref) - CENTAUR - CAL - 6x2x5mL
Siemens Healthcare Diagnostics Inc.
10334728
In Commercial Distribution

  • 00630414124926 ()
672182005

  • Multiple anaemia-related analyte IVD, calibrator
Ferritin/VitB12 - CENTAUR - CAL - 6x2x5mL
Siemens Healthcare Diagnostics Inc.
10311575
In Commercial Distribution

  • 00630414124919 ()
672182000

  • Multiple anaemia-related analyte IVD, calibrator
Multidil 1 - CENTAUR - CAL - 1x50mL
Siemens Healthcare Diagnostics Inc.
10311571
In Commercial Distribution

  • 00630414124841 ()
672177000

  • Buffered sample diluent IVD
CK-MB - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10311570
In Commercial Distribution

  • 00630414124803 ()
672174000

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator
Calibrator D - 2 pack (AFP Cal; CEA Cal)
Siemens Healthcare Diagnostics Inc.
10311569
In Commercial Distribution

  • 00630414124797 ()
672173000

  • Multiple tissue-associated protein/tumour marker IVD, calibrator
Ferritin/VitB12 - CENTAUR - CAL - 2x2x5mL
Siemens Healthcare Diagnostics Inc.
10311568
In Commercial Distribution

  • 00630414124780 ()
672172000

  • Multiple anaemia-related analyte IVD, calibrator
Cortisol Urin - CENTAUR - CTL - 1x50mL
Siemens Healthcare Diagnostics Inc.
10318246
In Commercial Distribution

  • 00630414121819 ()
570408

  • Total cortisol IVD, reagent
Calibration Verification Material for Hematocrit (CVM® Hct) is a unique material formulated to verify the calibration of conductivity-based hematocrit test systems.
Siemens Healthcare Diagnostics Inc.
10330034
In Commercial Distribution

  • 00630414121802 ()
570407

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
For in vitro diagnostic use for quality control of Hematocrit Analyzers.
Siemens Healthcare Diagnostics Inc.
10311393
In Commercial Distribution

  • 00630414121796 ()
  • 00630414009346 ()
570406

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
For in vitro diagnostic use for quality control of Hematocrit Analyzers.
Siemens Healthcare Diagnostics Inc.
10311392
In Commercial Distribution

  • 00630414121789 ()
  • 00630414009339 ()
570405

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Phenytoin - CENTAUR - CAL - 6x6x5mL
Siemens Healthcare Diagnostics Inc.
10314977
Not in Commercial Distribution

  • 00630414121772 ()
570404

  • Phenytoin therapeutic drug monitoring IVD, calibrator
Phenytoin - CENTAUR - CAL - 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10311391
Not in Commercial Distribution

  • 00630414121765 ()
570403

  • Phenytoin therapeutic drug monitoring IVD, calibrator
Phenytoin Master Curve Material - CENTAUR - CONS
Siemens Healthcare Diagnostics Inc.
10311390
Not in Commercial Distribution

  • 00630414121758 ()
570402

  • Phenytoin therapeutic drug monitoring IVD, control
For in vitro diagnostic use for verifying glucose and lactate sensor performance on the RAPIDLab® 1260 & 1265 systems
Siemens Healthcare Diagnostics Inc.
10311387
In Commercial Distribution

  • 00630414121628 ()
  • 00630414024516 ()
570097

  • Multiple blood gas analyte IVD, calibrator
Vancomycin - CENTAUR - CAL - 6x2x2mL
Siemens Healthcare Diagnostics Inc.
10330624
Not in Commercial Distribution

  • 00630414121451 ()
570062

  • Vancomycin therapeutic drug monitoring IVD, calibrator
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